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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01468701
Other study ID # 1160.129
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2011
Est. completion date January 10, 2020

Study information

Verified date March 2021
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Recruitment information / eligibility

Status Completed
Enrollment 37235
Est. completion date January 10, 2020
Est. primary completion date January 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: 1. Age =>18 years at enrollment 2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent 3. Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke. Other inclusion criteria apply. Exclusion criteria: 1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime; 3. AF with a generally reversible cause; 4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Clinica Coronel Suárez Buenos Aires
Argentina Consultorios Hematologicos SRL Buenos Aires
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Argentina Instituto Cardiovascular de Buenos Aires Buenos Aires
Argentina Instituto Cardiovascular de Corrientes Juana Francisca Cabra Corrientes
Argentina Hospital Espanol de Mendonza Godoy Cruz
Argentina Hospital Privado de Comunidad Mar del Plata
Argentina DIM Clinica Privada Ramos Mejía
Argentina Hospital Privado de Rosario Rosario
Argentina Consultorio del Dr. Aiub San Isidro
Argentina Sanatorio San Lucas San Isidro
Argentina Unidad Coronaria San Geronimo S.R.L. Santa Fe
Argentina Clinical Juncal Temperley
Argentina Sanatorio 9 de Julio S.A. Tucuman
Argentina Centro Privado de Cardiología Tucumán
Argentina CEMEDIC - Centro de Especialidades Medicas Villa Luro
Brazil Hospital Vera Cruz Belo Horizonte
Brazil Clinica Procardio Ltda Blumenau
Brazil Hospital do Coracao do Brasil Brasilia
Brazil Instituto de Cardiologia do Distrito Federal Brasilia
Brazil Hospital Angelina Caron Campina Grande do Sul
Brazil Centro Especializado em Cardiol Loema Instituto de Pesq Clin Campinas
Brazil HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas Campinas
Brazil Hospital Nossa Senhora de Pompeia Caxias do Sul
Brazil Irmandade da Santa Casa de Misericordia de Curitiba Curitiba
Brazil Barroso e Sebba Ltda Goiania
Brazil CLINICOR-Clinica de Exames Cardiolog e Ecografias S S LTDA Maceio
Brazil Hospital São Vicente de Paulo Passo Fundo
Brazil Fundacao Universitaria de Cardiologia - Inst de Cardiologia Porto Alegre
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre
Brazil Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares Recife
Brazil Fundacao Pro-Coracao FUNDACOR Rio de Janeiro
Brazil Hospital Copa D'or Rio de Janeiro
Brazil Fundacao Bahiana de Cardiologia Salvador
Brazil Instituto Cardiopulmonar da Bahia LTDA Salvador
Brazil Instituto de Ensino E Pesquisa Do Hospital Da Bahia Salvador
Brazil Instituto de Molestias Cardiovasculares - IMC Sao Jose do Rio Preto
Brazil Hcor - Hospital do Coracao Sao Paulo
Brazil Hospital Santa Marcelina Sao Paulo
Brazil Hospital Sao Paulo UNIFESP Sao Paulo
Brazil Instituto Dante Pazzanese de Cardiologia Sao Paulo
Brazil FGM - Clínica Paulista de Doenças Cardiovasculares São Paulo
Brazil H.S.J. Beneficência Portuguesa - São Paulo São Paulo
Brazil Hospital das Clinicas da Faculdade de Medicina - FMUSP São Paulo
Brazil Instituto de Molestias Cardiovasculares Tatui SP Tatui
Brazil Santa Casa de Votuporanga Votuporanga
Canada Antigonish Medical Associates Inc. Antigonish Nova Scotia
Canada Foothills Medical Centre Calgary Alberta
Canada Cambridge Cardiac Care Inc. Cambridge Ontario
Canada Q & T Research Chicoutimi Inc Chicoutimi Migration Data
Canada North Road Clinical Research Coquitlam British Columbia
Canada University of Alberta Hospital (University of Alberta) Edmonton Alberta
Canada West Lincoln Memorial Hospital Grimsby Ontario
Canada QEII Health Sciences Centre Halifax Nova Scotia
Canada Hamilton General Hospital Hamilton Ontario
Canada Hamilton Medical Research Group Hamilton Ontario
Canada Winterberry Family Medicine Hamilton Ontario
Canada Kelowna General Hospital Kelowna British Columbia
Canada Clinique de Cardiologie de Levis Levis Quebec
Canada Victoria Hospital (LHSC) London Ontario
Canada Mississauga Clinical Research Centre MIssissauga Ontario
Canada CHUM Hotel Dieu Montreal Quebec
Canada SKDS Research Incorporated Newmarket Ontario
Canada M Heffernan Medicine Professional Corp. Oakville Ontario
Canada Oshawa Clinic Cardiology Department, Oshawa, Courtice Oshawa Ontario
Canada Ottawa Hospital - Civic Campus Ottawa Ontario
Canada University of Ottawa Heart Institute Cardiology Research Ottawa Ontario
Canada Recherche Clinique Sigma Inc. Québec Quebec
Canada Crestwood Med & Dental Bldg Richmond British Columbia
Canada Saint John Regional Hospital Saint John New Brunswick
Canada IUCPQ (Laval University) Sainte-Foy Quebec
Canada Baycole Research Saskatoon Saskatchewan
Canada CHUS Fleurimont Sherbrooke Quebec
Canada CardioVasc HR Inc. St-Jean-sur-Richel Migration Data
Canada Eastern Health (MUN) St. John's Newfoundland and Labrador
Canada Aviva Clinical Trial Group Inc. Stoney Creek Ontario
Canada Ocean West Research Clinic Inc. Surrey British Columbia
Canada Keele Medical Place Toronto Ontario
Canada SGH Medical Mall Toronto Ontario
Canada St. Michael's Hospital Toronto Ontario
Canada Toronto General Hospital Toronto Ontario
Canada Toronto Western Hospital Toronto Ontario
Canada Victoria Cardiac Arrhythmia Trials Inc. Victoria British Columbia
Chile Centro de Estudios Clinicos Barros Luco Santiago
Chile Hospital Clínico Fuerza Aérea de Chile Santiago
Chile Hospital y CRS El Pino Santiago
Chile CECMI Ltda Temuco
Chile CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar Viña del Mar
Chile Clinica Tabancura Vitacura
China Beijing AnZhen Hospital Beijing
China Beijing Shijingshan Hospital Beijing
China Beijing Tsinghua Changgung Hospital Beijing
China Cardiovascular Institute and Fu Wai Hospital Beijing
China Peking Union Medical College Hospital Beijing
China Peking University First Hospital Beijing
China First Hospital of Jilin University Changchun
China 2nd Xiangya Hospital of Central South University Changsha
China Xiangya Hospital, Central South University Changsha
China Chinese Traditional Medicine Hospital of Sichuna Provinc Chengdu
China Center Hospital of Dalian Dalian
China Foshan Hospital of Southern Medical University Foshan
China Fujian Provincal Hospital Fuzhou
China Guangdong Provincial People's Hospital Guangzhou
China The First Affiliated Hospital of Jinan University Guangzhou
China The First Afiliated Hospital, Sun Yet-sen University Guangzhou
China Wu Jing Zong Dui Hospital of Guangdong Province Guangzhou
China Hangzhou First People's Hospital Hangzhou
China The Affiliated Hospital of Hangzhou Normal University Hangzhou
China Center Hospital of Jinan Jinan
China Qianfoshan Hospital affiliated to Shandong University Jinan
China Shandong Jiaotong Hospital Jinan
China Shandong Provincial Hospital Jinan
China Jining No.1 people's hospital Jining
China The Second Affiliated Hospital to Nanchang University Nanchang
China Zhongda Hospital Southeast University Nanjing
China Chinese People's Liberation Army 401 Hospital Qingdao
China Qingdao Central Hospital Qingdao
China Qingdao Fuwai Hospital Qingdao
China QingDao Municipal Hospital QingDao
China The affiliated hospital of medicalcollege qingdao university Qingdao
China Huashan Hospital, Fudan University Shanghai
China Jiading Hospital Shanghai
China Minhang District Central Hospital Shanghai
China Renji Hospital Shanghai Jiaotong Univesrity School of Medicine Shanghai
China Shanghai East Hospital, Tongji University China Shanghai
China Shanghai Huadong Hospital Shanghai
China Songjiang Hospital Shanghai
China Tongji Hospital, Tongji University Shanghai
China General Hospital of Shenyang Military Region Shenyang
China People's Hospital of Liaoning Province Shenyang
China Shengjing Hospital of China Medical University Shenyang
China The Forth People's Hospital of Shenzhen Shenzhen
China Hebei Provincial Tumor Hospital Shijiazhuang
China The Second Hospital of Hebei Medical University Shijiazhuang
China SuZhou Kowloon Hospital Suzhou
China The Central Hospital of Tai'an Tai'an
China Shanxi Cardiovascular Hospital Taiyuan
China Wu Jing Yi Xue Yuan Fu Shu Yi Yuan Tianjin
China Hubei Province Zhongshan Hospital Wuhan
China Wuhan Asia Heart Hospital Wuhan
China First Affiliated Hospital of Xiamen University Xiamen
China Xiamen Cardiovascular Hospital Xiamen University Xiamen
China Xuzhou Central Hospital Xuzhou
China Subei People's Hospital Yangzhou
China Zhengzhou Central Hospital Zhengzhou
China zhengzhou No.7 people's Hospital Zhengzhou
China Zhengzhou People'S Hospital Zhengzhou
China Yankuang Group General Hospital Zoucheng
Colombia Fundacion Clinica Shaio Bogota
Colombia Fundacion Hospital Infantil Universitario de San José Bogotá
Colombia Simedics Ips Bogotá
Colombia Hospital Santa Clara E.S.E. Bogota DC
Colombia Fundacion Valle de Lilly Cali
Colombia Centro Médico Julián Coronel Cali -Valle Del Cauca
Colombia Centro de Diagnostico Cardilogico Cartagena de Indias
Colombia Fundacion Cardiovascular de Colombia Floridablanca
Colombia Asociacion IPS Medicos Internistas de Caldas Manizales
Colombia Ces Cardiología Medellin
Colombia Ciclam Sas Medellín
Colombia Fundacion Cardiomet Centro de Investigaciones CEQUIN Quindio
Ecuador Hospital Teodoro Maldonado Carbo Guayaquil
Ecuador Unicormed SA Guayaquil
Ecuador Hospital INTERVASCU Quito
Hong Kong Prince of Wales Hospital Hong Kong
Hong Kong Princess Margaret Hospital Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Japan Asahi General Hospital Chiba, Asahi
Japan Seikeikai New Tokyo Heart Clinic Chiba, Matsudo
Japan Saiseikai Matsuyama Hospital Ehime, Matsuyama
Japan Fukuiken Saiseikai Hospital Fukui, Fukui
Japan Japanese Red Cross Fukuoka Hospital Fukuoka, Fukuoka
Japan Aso Co.,Ltd Iizuka Hospital Fukuoka, Iizuka
Japan Nakamura Cardiovascular Clinic Fukuoka, Itoshima
Japan Fukuoka Tokushukai Medical Center Fukuoka, Kasuga
Japan Shin Komonji Hospital Fukuoka, Kitakyushu
Japan Fukuoka Shin Mizumaki Hospital Fukuoka, Onga
Japan Matsuda Cardiovascular Clinic Hokkaido, Sapporo
Japan Kobe City Medical Center General Hospital Hyogo, Kobe
Japan Higashi Takarazuka Satoh Hospital Hyogo, Takarazuka
Japan Houju Memorial Hospital Isikawa, Nomi
Japan KKR Takamatsu Hospital Kagawa , Takamatsu
Japan Kagawa Prefectural Shirotori Hospital Kagawa, Higashikagawa
Japan Kokan Clinic Kanagawa, Kawasaki
Japan Sekishinkai Kawasaki Saiwai Clinic Kanagawa, Kawasaki
Japan Sagamihara Kyodo Hospital Kanagawa, Sagamihara
Japan Nakayama Clinic of I.M. and Cardiology, Kochi, Cardiology Kochi, Kochi
Japan Social Medical Corporation Chikamorikai Chikamori Hospital Kochi, Kochi
Japan Sugimurakai Medical Association Sugimura Hospital Kumamoto, Kumamoto
Japan Japan Community Health care Organization Kumamoto General Hospital Kumamoto, Yatsushiro
Japan Uji-Tokushukai Medical Center Kyoto, Uji
Japan Iida Municipal Hospital Nagano, Iida
Japan Suwa Red Cross Hospital Nagano, Suwa
Japan Tachikawa General Hospital Niigata, Nagaoka
Japan Nozaki Tokushukai Hospital Osaka, Daito
Japan Teramoto Memorial Hospital Osaka, Kawachinagano
Japan Matsubara Tokushukai Hospital Osaka, Matsubara
Japan Kitano Hospital Osaka, Osaka
Japan Osaka Kaisei Hospital Osaka, Osaka
Japan Osaka Saiseikai Nakatsu Hospital Osaka, Osaka
Japan Ishinkai General Clinics Osaka, Yao
Japan Medical corporation Chisei-kai Watanabe clinic Saitama, Okegawa
Japan SAINO Clinic Saitama, Tokorozawa
Japan Kusatsu Heart Center Shiga, Kusatsu
Japan Shizuoka Tokushukai Hospital Shizuoka, Shizuoka
Japan The Institute for Adult Deseases, Asahi Life Foundation Tokyo, Chuo-ku
Japan Minamino Heart Clinic Tokyo, Hachioji
Japan Shimizu Clinic Tokyo, Kodaira
Japan The Cardiovascular Institute Hospital Tokyo, Minato-ku
Japan YOGA Urban Clinic Tokyo, Setagaya
Japan The University of Toyama Hospital Toyama, Toyama
Korea, Republic of Sejong General Hospital Bucheon
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Kosin University Gospel Hospital Busan
Korea, Republic of Pusan National Univ. Hosp Busan
Korea, Republic of Daegu Fatima Hospital Daegu
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National Univ. Hosp Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Eulji University Hospital Daejeon
Korea, Republic of The Catholic University of Korea, Daejeon St.Mary's Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Wonkwang University Hospital Iksan
Korea, Republic of Jeju National University Hospital Jeju
Korea, Republic of Chonbuk National University Hospital Jeonju
Korea, Republic of Gyeongsang National University Hospital Jinju
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangdong Sacred Heart Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Kyung Hee University Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St.Mary's Hospital Seoul
Korea, Republic of VHS Medical Center Seoul
Korea, Republic of Ajou University Hospital Suwon
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Pusan National University Yangsan Hospital Yangsan
Lebanon St.Charles Hospital Baabda
Lebanon Al Rassoul Hospital, Beirut Cardiac Institute Beirut
Lebanon American University of Beirut Medical Center Beirut
Lebanon Bellvue Medical Center, Beirut Beirut
Lebanon Hotel Dieu de France Hospital Beirut
Lebanon Makassed General Hospital Beirut
Lebanon Rafik Hariri University Hospital Beirut
Lebanon St. Georges Hospital Beirut
Lebanon Notre Dame de Secours Hospital Byblos
Lebanon Hammoud Hospital University Medical Center Saida
Mexico Hospital General de Acapulco Acapulco De Juárez, Guerrero
Mexico Hospital Cardiologica Aguascalientes Aguascalientes
Mexico Christius Muguerza Hospital del Parque Chihuahua
Mexico Centro Especializado de Investigación Medical Group Culiacan Culiacan
Mexico Centro para el Desarrollo de la Medicina y de Asist Med Espe Culiacan
Mexico Instituto Nacional de Cardiologia Ignacio Chavez Distrito Federal
Mexico Unidad Coronariana del Hospital General de Durango Durango
Mexico Centro de Investigación Especializada de Occidente S.C. Guadalajara
Mexico Clínica de Estudios Médicos S.C. Guadalajara
Mexico ICLE SC Guadalajara
Mexico Private Practice Guadalajara
Mexico Centro Medico de las Americas Mérida, Yucatán
Mexico Paracelsus S. A. de C.V. Mexico
Mexico Hospital Metropolitano "Dr Bernardo Sepulveda" Monterrey
Mexico Clinica Miravalle Monterrey, Nuevo Leon
Mexico Unidad de Investigacion Clinica en Medicina, S.C. Monterrrey
Mexico Consultorio Privado J Arturo Maldonado Villalon Morelia, Michoacan
Mexico Clinical Medical Research S.C Orizaba
Mexico Instituto de Corazón de Querétaro Querétaro
Mexico Cardioarritmias e Investigación S.C San Luis Potosi
Mexico Plaza Medical Tijuana
Mexico Servicios Diagnosticos en Medicina SC Toluca, Estado De Mexico
Mexico iBiomed Zapopan
Peru Centro Medico Monte Carmelo Arequipa
Peru Hospital Nacional Daniel Alcides Carrion Bellavista
Peru EsSalud - Hospital Nacional IV Alberto Sabogal Sologuren Callao
Peru Hospital Nacional Guillermo Almenara Irigoyen La Victoria
Peru Clinica San Pablo Lima
Peru Hospital Nacional Edgardo Rebaglini Martins Lima
Peru Centro de Investigación en Diabetes, Obesidad y Nutrición Lince
Peru Clinica Internacional San Borja
Peru Clinica Vesalio San Borja
Peru Clinica El Golf San Isidro
Peru Clinica Medica Cayetano Heredia San Martin de Porres
Russian Federation Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul Barnaul
Russian Federation Chelyabinsk State Med.Acad, Dept. of Clinical Pharmacology Chelyabinsk
Russian Federation Chita State Med.Acad, Consultative-Diagnostic-Polyclinic Chita
Russian Federation OJSC Municipal Instit.Dzerjinskiy City Hospital Dzerjinskiy
Russian Federation GBUZ SO Ural Institute of Cardiology, Ekaterinburg Ekaterinburg
Russian Federation Road Clin.Hosp.Irkutsk-Russian Railways,Cardio.&Therapy Dept Irkutsk
Russian Federation City Clin.Hosp.#9,Intern.Diseases&Fam.Practice Dept, Izhevsk Izhevsk
Russian Federation Res.Inst.-Compl.Iss.Cardi.Dis. Kemerovo
Russian Federation Municipal Instit. City Hosp. No.2, Policlinic Dept,Krasnodar Krasnodar
Russian Federation GOU VPO MUZ City Clinical Hospital No. 20, Krasnoyarsk Krasnoyarsk
Russian Federation Moscow 1st State Med.Univ.n.a.I.M.Sechenov Moscow
Russian Federation Research Center n.a.A.N.Bakulev,Clin.-Diagnostic Dept,Moscow Moscow
Russian Federation Russian Cardiology Research and Production Complex, Moscow Moscow
Russian Federation Reg.Clin.Cardiological Dispen,Arrhythmology Dept,Novosibirsk Novosibirsk
Russian Federation Omsk State Medical Acad.,Internal Diseases&Fam.Practice Dept Omsk
Russian Federation Orenburg State Medical Academy of MoH, Therapy Department Orenburg
Russian Federation Instit.Healthcare,MedicalSanitary Unit 9,n.a.M.A.Tverie,Perm Perm
Russian Federation Rostov Regional Clinical Hospital Rostov-on-Don
Russian Federation Ryazan Reg.Clin.Hosp.Internal Diseases&Policlin.Therapy Dept Ryazan
Russian Federation Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept. Samara
Russian Federation Samara State Medical University, Chair of Faculty Therapy Samara
Russian Federation Municipal Instit.Healthcare,City Policlinic #6,Therapy Dept. Saratov
Russian Federation Fed.Centre of Heart, Blood & Endocrinology n.a. V.A. Almazov St. Petersburg
Russian Federation Pokrovskaya City Hospital, St.Petersburg St. Petersburg
Russian Federation Primorskiy Regional Clinical Hospital No. 1 Vladivostok
Saudi Arabia King Fahad Military Hospital Dammam
Saudi Arabia King Fahad Hufuf Hospital Hufuf
Saudi Arabia Khamis Military Hospital Jeddah
Saudi Arabia King Abdul Aziz University Hospital Jeddah
Saudi Arabia King Salman Hospital Riyadh
Saudi Arabia Prince Salman Heart Center Riyadh
Saudi Arabia Tabuk Military Hospital Tabuk
Saudi Arabia King Faisal Hospital Taif
Singapore National Heart Center Singapore
Singapore National Neuroscience Institute Singapore
Singapore National University Hospital Singapore
Singapore Novena Heart Centre Singapore
South Africa Dr Mahesh Duki Research and Trial Site Durban
South Africa Dr. N. Ranjith Durban
South Africa LCS Clinical Research Unit Johannesburg
South Africa Helderberg Research Institute Somerset West, Cape Town
South Africa Dr. Moodley and Dr. Sarvan Tongaat
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan NCKUH Tainan
Taiwan Cathay General Hospital Taipei
Taiwan Cheng Hsin General Hospital Taipei
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Memorial Hospital(Linkou) Taoyuan
United Arab Emirates Al Ain Hospital Abu Dhabi
United Arab Emirates Sheikh Khalifa Medical City Abu Dhabi
United Arab Emirates Dubai Hospital Dubai
United Arab Emirates Al Qassimi Hospital Sharjah
United States Abington Medical Specialists Abington Pennsylvania
United States Albany Medical Center / Albany Medical College Albany New York
United States Lovelace Scientific Resources, Inc. Albuquerque New Mexico
United States Cambridge Medical Trials Alexandria Louisiana
United States Endeavor Medical Research Alpena Michigan
United States McFarland Clinic PC Ames Iowa
United States Alaska Heart Institute Anchorage Alaska
United States AnMed Health Clinical Research Anderson South Carolina
United States Internal Medicine Associates of Anderson, PA Anderson South Carolina
United States Cardiac Consultants, LLC Annapolis Maryland
United States Northwest Heart Clinical Research, LLC Arlington Heights Illinois
United States Executive Health and Research Associates Atlanta Georgia
United States Saint Joseph's Research Institute Atlanta Georgia
United States Aurora Denver Cardiology Associates, PC Aurora Colorado
United States THV Research, LLC Austin Texas
United States Aventura Institute for Cardiovascular Wellness, PA Aventura Florida
United States Primary Care Cardiology Research, Inc Ayer Massachusetts
United States MedStar Health Research Institute Baltimore Maryland
United States Cardiovascular Research Foundation of Louisiana Baton Rouge Louisiana
United States McLaren Bay Region Medical Center Bay City Michigan
United States Lowcountry Medical Group, LLC Beaufort South Carolina
United States Southeast Texas Clinical Research Center Beaumont Texas
United States Southern Maine Health Care Biddeford Maine
United States The Center for Clinical Trials, Inc. Biloxi Mississippi
United States Grace Research, LLC Bossier City Louisiana
United States Bay Area Cardiology Brandon Florida
United States Bridgeport Hospital Bridgeport Connecticut
United States Connecticut Clinical Research, LLC Bridgeport Connecticut
United States Connecticut Heart and Vascular Center Bridgeport Connecticut
United States Medicor Cardiology Bridgewater New Jersey
United States Genesys Research Institute, Incorporated Brighton Massachusetts
United States Cardiac Care and Vascular Medicine, PLLC Bronx New York
United States New York -Presbyterian Brooklyn Methodist Hospital Brooklyn New York
United States Hendricks Family Medicine Brownsburg Indiana
United States Burke Internal Medicine and Research Burke Virginia
United States Kernodle Clinic West Burlington North Carolina
United States Cooper University Hospital Camden New Jersey
United States Community Cardiology Camillus New York
United States Capital Area Research, LLC Camp Hill Pennsylvania
United States Aultman Hospital Canton Ohio
United States Prairie Cardiovascular Memorial Hospital Carbondale Illinois
United States Preferred Primary Care Phys Carnegie Pennsylvania
United States Chambersburg Hospital Chambersburg Pennsylvania
United States CAMC Clinical Trials Center Charleston West Virginia
United States University of Virginia Health System Charlottesville Virginia
United States Office of Yvonne Chester Chattanooga Tennessee
United States Cardiovascular Associates, Ltd Chesapeake Virginia
United States Captain James A. Lovell Federal Health Care Center Chicago Illinois
United States John H. Stroger Jr. Hospital of Cook Country Chicago Illinois
United States Medex Healthcare Research Chicago Illinois
United States North Shore Cardiology Consultants Chicago Illinois
United States University of Chicago Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Tampa Bay Medical Research Clearwater Florida
United States The MetroHealth System Cleveland Ohio
United States MedStar Southern Maryland Hospital Center Clinton Maryland
United States Kootenai Heart Clinics, LLC Coeur d'Alene Idaho
United States Lynn Institute of the Rockies Colorado Springs Colorado
United States Pikes Peak Cardiology Colorado Springs Colorado
United States Cardiovascular Specialists of Central Maryland Columbia Maryland
United States South Carolina Heart Center Columbia South Carolina
United States Bassett Medical Center Cooperstown New York
United States Good Samaritan Hospital Corvallis Corvallis Oregon
United States Atlanta Heart Specialists, LLC Cumming Georgia
United States Dallas VA Medical Center Dallas Texas
United States Heartplace Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Cardiology Consultants of Danville, Inc Danville Virginia
United States William C McGarity, Jr, MD, PC Decatur Georgia
United States Seidman Clinical Trials Delray Beach Florida
United States Denver Health Medical Center Denver Colorado
United States Henry Ford Hospital K-15 Detroit Michigan
United States Universal Clinical Research Associates Doral Florida
United States Central Bucks Cardiology Doylestown Pennsylvania
United States Essentia Heart and Vascular Clinic Duluth Minnesota
United States Monmouth Cardiology Associates Eatontown New Jersey
United States Central Cardiology Associates Elizabethtown Kentucky
United States Diagnamics, Inc Encinitas California
United States Physician Specialist of Northern Lancaster County Medcl Grp Ephrata Pennsylvania
United States St. Vincent Consultants in Cardiovascular Disease, LLC Erie Michigan
United States Northwestern University Evanston Illinois
United States Mercy Health Fairfield Hospital Fairfield Ohio
United States Advanced Heart Care, LLC, Medicoricum, LLC Fairview Heights Illinois
United States Cleveland Cardiovascular Research Foundation Fairview Park Ohio
United States NECCR Internal Med and Cardio Fall River Massachusetts
United States Inova Research Center Falls Church Virginia
United States Virginia Heart Falls Church Virginia
United States Lillestol Research, LLC Fargo North Dakota
United States Cardiology Consultants of East Michigan Flint Michigan
United States New York Hospital Queens Flushing New York
United States Sparks Regional Medical Center Fort Smith Arkansas
United States Parkview Research Center Fort Wayne Indiana
United States Amir Malik Research Fort Worth Texas
United States Allianz Medical and Research Center Fountain Valley California
United States Mary Washington Hospital Research Department Fredericksburg Virginia
United States B&K Medical Research Center Fresno California
United States Cardiovascular Research of North Florida LLC Gainesville Florida
United States Phoenix Heart PLLC Glendale Arizona
United States Genesys Heart Institute Grand Blanc Michigan
United States Regional Cardiology Associates Grand Blanc Michigan
United States State of the Heart Cardiology Grapevine Texas
United States Piedmont Cardiology Associates, P.A. Greenwood South Carolina
United States Electrophysiology Associates of Northern New Jersey Hackensack New Jersey
United States Advocare Heights Primary Care Haddon Heights New Jersey
United States Heart Clinic of Hammond Hammond Louisiana
United States Associated Cardiovascular Consultants Lourdes Hammonton New Jersey
United States Harleysville Medical Associates Harleysville Pennsylvania
United States Harrisonburg Medical Associates Harrisonburg Virginia
United States American Clinical Trials Hawaiian Gardens California
United States Magi Research Clinic, Inc Hialeah Florida
United States Clinical Trials of America, Inc Hickory North Carolina
United States Carolina Cardiology Cornerstone High Point North Carolina
United States Adventist Health Partners, Inc Hinsdale Illinois
United States Global Research Solutions Corporation Hollywood Florida
United States Dr. Michael A. Frais, Cardiologist, P.A. Hot Springs Arkansas
United States Mercy Cinic Hot Springs Communities Hot Springs Arizona
United States Angiocardiac Care of Texas Houston Texas
United States Barry Troyan, M.D, PA Houston Texas
United States Centex Studies, Inc. Houston Texas
United States Dairy Ashford Family Pratice Houston Texas
United States Houston Methodist DeBakey Cardiology Associates Houston Texas
United States Emil Hayek, M.D., Inc Hudson Ohio
United States Cardiovascular Associates PLLC Humble Texas
United States St. Mary's Medical Center Huntington West Virginia
United States University Cardiovascular Services Huntington West Virginia
United States St. Vincent Medical Group Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States The Jackson Clinic, PA Jackson Tennessee
United States University Of Mississippi Medical Center Jackson Mississippi
United States Profen Research Network at East Carolina Medical Associates Jacksonville North Carolina
United States St. Vincent's Ambulatory Care Jacksonville Florida
United States Lycoming Internal Medicine, Inc Jersey Shore Pennsylvania
United States Center For Cardiovascular Research Johnson City Tennessee
United States UHS Office of Clinical Trials Johnson City New York
United States Tenet Florida Physician Services Jupiter Florida
United States Kalispell Regional Medical Center Kalispell Montana
United States Kannapolis Internal Medicine Kannapolis North Carolina
United States Health Midwest Ventures Group, Inc Kansas City Missouri
United States Cardiology Center of Houston, PA Katy Texas
United States Innovation Center, Kettering Medical Center Kettering Ohio
United States Texas Cardiology Research Center PLLC Kingwood Texas
United States PMG Research of Knoxville Knoxville Tennessee
United States PMG Research of Knoxville Knoxville Tennessee
United States Tennova Healthcare-Turkey Creek Medical Center Knoxville Tennessee
United States Mayo Clinic-Sparta La Crosse Wisconsin
United States Scripps Clinic La Jolla California
United States La Mesa Cardiac Center La Mesa California
United States Cardiovascular Specialists of Southwest Louisiana, LLC Lake Charles Louisiana
United States Midwest Internal Medicine, PLLC Lake Havasu City Arizona
United States Watson Clinic Center for Research, Inc Lakeland Florida
United States Cardiology Consultants of Philadelphia Lansdale Pennsylvania
United States Thoracic and Cardiovascular Healthcare Foundation Lansing Michigan
United States Beacon Medical Group Clinical Research LaPorte Indiana
United States Clinical Trials of America, Inc Lenoir North Carolina
United States NJ Heart LLC Linden New Jersey
United States Arkansas Cardiology, PA Little Rock Arkansas
United States Cardiology and Medicine Clinic Little Rock Arkansas
United States Donald W. Reynolds Institute on Aging Little Rock Arkansas
United States South Denver Cardiology Associates, PC Littleton Colorado
United States Los Alamitos Cardiovascular Los Alamitos California
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States Robley Rex VA Medical Center Louisville Kentucky
United States Caprock Cardiac Center Research Institute Lubbock Texas
United States Coliseum Medical Center Macon Georgia
United States Baptist Health Clinical Studies Madisonville Kentucky
United States Garden State Heart Care, PC Manalapan New Jersey
United States Manassas Clinical Research Center Manassas Virginia
United States Frederick C Smith Clinic Inc Marion Ohio
United States RAS Health Ltd Marion Ohio
United States Upper Michigan Cardiovascular Associates, PC Marquette Michigan
United States Consultants in Cardiovascular Medicine Melrose Park Illinois
United States Medpharmics, LLC Metairie Louisiana
United States A&L Clinical Research Miami Florida
United States Cardiovascular Research Center of South Florida Miami Florida
United States Global Research Solutions Corporation Miami Florida
United States Miami Center for Cardiovascular Disease Miami Florida
United States New Horizon Research Center Miami Florida
United States Mound Family Practice Miamisburg Ohio
United States Cardiovascular Associates of Virginia Midlothian Virginia
United States Family Medical Clinic Milwaukee Wisconsin
United States Karim Bakhtiar MD, SC Milwaukee Wisconsin
United States Milwaukee VA Medical Center Milwaukee Wisconsin
United States Wheaton Franciscan Milwaukee Wisconsin
United States Long Island Heart Associates Mineola New York
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Trinity Health Center Medical Arts Minot North Dakota
United States Sacred Heart Medical Specialty Group Miramar Beach Florida
United States University South Alabama Medical Center Mobile Alabama
United States Koch Family Medicine Morton Illinois
United States McLaren-Macomb Mount Clemens Michigan
United States Office of Dr. Paul McLaughlin, M.D. Mount Sterling Kentucky
United States Cardiology Associates of Northwest Indiana, PC Munster Indiana
United States Family Medicine of SayeBrook Myrtle Beach South Carolina
United States Collier HMA Physician Management Naples Florida
United States Atlantic Cardiology, LLC Neptune New Jersey
United States Mission Research Institute, LLC New Braunfels Texas
United States Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey
United States LSU Health Sciences Center New Orleans Louisiana
United States Edgewater Medical Research New Smyrna Beach Florida
United States Chinatown Cardiology, PC New York New York
United States Lenox Hill Hospital New York New York
United States Saint Luke - Roosevelt Hospital Center New York New York
United States Red Clay Research LLC. Newark Delaware
United States Newton-Wellesley Hospital Newton Massachusetts
United States South Western Medical Clinic Niles Michigan
United States Black Warrior Research Northport Alabama
United States Mehrdad Kevin Ariani, MD, Incorporated Northridge California
United States Cardiology Associates of Fairfield County Norwalk Connecticut
United States Norwalk Medical Group Norwalk Connecticut
United States Providence Park Hospital Novi Michigan
United States SouthEast Medical Centre Oakland Park Florida
United States Oklahoma Foundation for Cardiovascular Research Oklahoma City Oklahoma
United States Board of Regents of the University of Nebraska Omaha Nebraska
United States Meridian Clinical Research, LLC Omaha Nebraska
United States MidAmerica Cardiovascular Institute Omaha Nebraska
United States Research One Orlando Florida
United States Midwest Heart and Vascular Specialists Overland Park Kansas
United States Research Integrity, LLC Owensboro Kentucky
United States VA Palo Alto Health Care System Palo Alto California
United States Alegent Health Heart and Vascular Specialists Papillion Nebraska
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Memorial Hospital of RI Pawtucket Rhode Island
United States South Florida Research Solutions, LLC Pembroke Pines Florida
United States Langhorne Cardiology Consultants, Inc Pensacola Florida
United States Einstein Medical Center Philadelphia Philadelphia Pennsylvania
United States Pennsylvania Cardiology Associates Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Pinehurst Medical Clinic, Inc Pinehurst North Carolina
United States Allegheny Neurology Associates Pittsburgh Pennsylvania
United States VNH Heart Center Research Port Charlotte Florida
United States Sound Medical Research Port Orchard Washington
United States Fanno Creek Clinic, LLC Portland Oregon
United States Wake Heart Research Raleigh North Carolina
United States Eisenhower Desert Cardiology Center Rancho Mirage California
United States Black Hills Cardiovascular Research Rapid City South Dakota
United States Renown Institute for Heart and Vascular Health Reno Nevada
United States VA Sierra Nevada Health Care System Reno Nevada
United States CJW Medical Center - Chippenham Richmond Virginia
United States The Valley Hospital Ridgewood New Jersey
United States Carilion Clinic Roanoke Virginia
United States Advanced Cardiovascular Consultants Rock Island Illinois
United States Brevard Cardiovascular Research Associates, Inc Rockledge Florida
United States Covenant Medical Center, Inc. Saginaw Michigan
United States MId-MIchigan Heart and Vascular Center Saginaw Michigan
United States CentraCare Heart and Vascular Center Saint Cloud Minnesota
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Consult and Research Associates Saint Louis Missouri
United States Gateway Cardiology, PC Saint Louis Missouri
United States Saint Louis University Saint Louis Missouri
United States United Heart and Vascular Clinic Saint Paul Minnesota
United States Alternative Solutions Medical Research and Prevention Center Saint Petersburg Florida
United States Northside Hospital Saint Petersburg Florida
United States Suncoast Cardiovascular Research Inc. Saint Petersburg Florida
United States Salem VA Medical Center Salem Virginia
United States Delmarva Heart Research Foundation, Inc Salisbury Maryland
United States Peninsula Cardiology Associates Salisbury Maryland
United States Heart Center at Saint Mark's Salt Lake City Utah
United States Highland Clinical Research Salt Lake City Utah
United States Mercury Medical ,LLC San Antonio Texas
United States Texas Medical Research Associates San Antonio Texas
United States Ritchken and First MD's San Diego California
United States Coastal Heart Group Inc Santa Ana California
United States Cardiovascular Center of Sarasota Sarasota Florida
United States Velella Research, Inc Sarasota Florida
United States Saratoga Clinical Research, LLC Saratoga Springs New York
United States Scottsboro Quick Care Clinic Scottsboro Alabama
United States Sealy Urgent Care Center and Medical Clinic Sealy Texas
United States The Polyclinic Seattle Washington
United States Seguin Institute of Cardiovascular Research Seguin Texas
United States Grand View - Lehigh Valley Health Services Sellersville Pennsylvania
United States James C. Neiman, MD Seminole Florida
United States Heart Specialists, PC of Southern CT Shelton Connecticut
United States Advanced Cardiovascular Specialists Shreveport Louisiana
United States Louisiana Heart Center Slidell Louisiana
United States Heart and Vascular Center of New Brunswick Somerset New Jersey
United States Beacon Medical Group Clinical Research South Bend Indiana
United States Central New Jersey Cardiology South Plainfield New Jersey
United States Heart House Research Foundation, LLC Springfield Ohio
United States Sacred Heart Medical Center at RiverBend Springfield Oregon
United States Pacific Heart and Vascular Stockton California
United States Stony Brook Cardiology/Electrophysiology Stony Brook New York
United States Sugarland Cardiology Sugar Land Texas
United States New York Heart Center Syracuse New York
United States SUNY Upstate Medical University Syracuse New York
United States Franciscan Heart and Vascular Associates Tacoma Washington
United States Tallahassee Research Instutite Tallahassee Florida
United States University of South Florida Tampa Florida
United States Southwest Heart Institute Temecula California
United States Cardiovascular Research Center Toledo Ohio
United States Toledo Clinic Incorporated Toledo Ohio
United States University of California Los Angeles Torrance California
United States Chesapeake Cardiovascular Associates Towson Maryland
United States Cardiovascular Associates of East Texas, PA Tyler Texas
United States Trinity Clinic Tyler Texas
United States University of Texas Health Science Center at Tyler Tyler Texas
United States Cardiology Associates Medical Group Inc Ventura California
United States Ventura Cardiology Consultants Medical Group, Inc Ventura California
United States Ventura Clinical Trials Ventura California
United States Indian River Medical Associates Cardiology Vero Beach Florida
United States Office of Dr. David J Cislowski MD Visalia California
United States Associated Cardiovascular Consultants Lourdes Voorhees New Jersey
United States Providence Health Services of Waco Waco Texas
United States South County Cardiology Wakefield Rhode Island
United States Warminster Medical Associates, PC Warminster Pennsylvania
United States Cardiac Arrhythmia Center Washington District of Columbia
United States Howard University Hospital Washington District of Columbia
United States Medical Faculty Associates, Inc Washington District of Columbia
United States Northeast Iowa Medical Education Foundation Waterloo Iowa
United States ProHealth Care Research Institute and Cardiology Associates Waukesha Wisconsin
United States Cardiology Partners Clinical Research Institute Wellington Florida
United States The Iowa Clinic, PC West Des Moines Iowa
United States NJ Cardiology Associates West Orange New Jersey
United States Great Lakes Medical Research Westfield New York
United States Hill County Primary Care Whitney Texas
United States Cardiology Group of Western New York, PC Williamsville New York
United States Great Lakes Medical Research, LLC Willoughby Ohio
United States Wake Heart and Vascular Associates Wilson North Carolina
United States Selma Medical Associates, Winchester Winchester Virginia
United States DuPage Medical Group Winfield Illinois
United States Cardiac and Thoracic Institute of Central Washington Yakima Washington
United States Cardiology Consultants of Philadelphia Yardley Pennsylvania
United States Ohio Heart Institute Youngstown Ohio
United States INTEGRIS Ambulatory Care Corporation Yukon Oklahoma
Venezuela Instituto de Clinicas y Urologia Tamanaco San Roman Caracas

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Brazil,  Canada,  Chile,  China,  Colombia,  Ecuador,  Hong Kong,  Japan,  Korea, Republic of,  Lebanon,  Mexico,  Peru,  Russian Federation,  Saudi Arabia,  Singapore,  South Africa,  Taiwan,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase II Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) - Phase III Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown cause of death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase II Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only. In case of multiple events for a patient, the first event was considered. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) - Phase III Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. Counts were based on the average of the 20 restricted data sets. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Stroke or Systemic Embolism - Phase III Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Stroke - Phase II Incidence rate of stroke on all eligible patients excluding prescribed but not taken set for Dabigatran etexilate (DE) of phase II only is presented. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Stroke - Phase III Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Transient Ischaemic Attack (TIA) - Phase II Incidence rate of transient ischaemic attack (TIA) on on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Transient Ischaemic Attack (TIA) - Phase III Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Systemic Embolism (SE) - Phase II Incidence rate of systemic embolism (SE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Systemic Embolism (SE) - Phase III Incidence rate of systemic embolism (SE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Pulmonary Embolism (PE) - Phase II Incidence rate of pulmonary embolism (PE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Pulmonary Embolism (PE) - Phase III Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Major Bleeding Events (MBE) - Phase II Incidence rate of major bleeding events (MBE) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Major Bleeding Events (MBE) - Phase III Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Life-threatening Bleeding Events - Phase II Incidence rate of life-threatening bleeding events on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Life-threatening Bleeding Events - Phase III Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Myocardial Infarction (MI) - Phase II Incidence rate of myocardial infarction (MI) on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Myocardial Infarction (MI) - Phase III Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of All-cause Death - Phase II Incidence rate of all-cause death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of All-cause Death - Phase III Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Vascular Death - Phase II Incidence rate of vascular death on all eligible patients excluding prescribed but not taken set that included Dabigatran etexilate (DE) of phase II only is presented. From baseline visit of Phase II until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 2 years.
Primary Incidence Rate of Vascular Death - Phase III Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) of phase III and Vitamin K Antagonist (VKA) of phase III only. From baseline visit of phase III until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
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