Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Atrial Fibrillation Clinical Trial

Official title:

A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164864
• Other study ID #: 1160.186
• Secondary ID: 2013-003201-26
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2014
• Est. completion date: June 5, 2017

Study information

• Verified date: July 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2725
• Est. completion date: June 5, 2017
• Est. primary completion date: June 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male or female patients aged >=18 years

• Patients with Non Valvular Atrial Fibrillation

• Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

• The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria:

• Patients with a mechanical or biological heart valve prosthesis

• Cardiogenic shock during current hospitalisation

• Stroke within 1 month prior to screening visit

• Patients who have had major surgery within the month prior to screening

• Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated

• Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit

• Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening

• Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening

• Active liver disease

Related Conditions & MeSH terms

• Atrial Fibrillation
• Percutaneous Coronary Intervention

Intervention

Drug:
• Dabigatran Etexilate 110mg
Active treatment
• Warfarin 3mg
Active comparator
• Aspirin
Active comparator
• Dabigatran Etexilate 150mg
Active treatment
• Clopidogrel or Ticagrelor
Active comparator
• Clopidogrel or Ticagrelor
Active comparator
• Warfarin 5mg
Active comparator
• Clopidogrel or Ticagrelor
Active comparator
• Warfarin 1mg
Active comparator

Locations

Country	Name	City	State
Argentina	Fundación Favaloro	Caba
Argentina	Hospital Italiano de Buenos Aires	Caba
Argentina	Instituto Cardiovascular de Buenos Aires	Caba
Argentina	Consultorios Asociados de Endocrinología e Invest Clínica	Capital Federal
Argentina	Sanatorio Allende	Córdoba
Argentina	Instituto de Cardiología de Corrientes	Corrientes
Argentina	Instituto CER	Quilmes
Argentina	Inst.Cardiovascular San Luis	San Luis
Argentina	Investigaciones Clinicas Tucumán	San Miguel de Tucumán
Australia	Pendlebury Research	Adamstown	New South Wales
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Heartcare Victoria	Bundoora	Victoria
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	The Geelong Hospital	Geelong	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Wollongong Hospital	Wollongong	New South Wales
Austria	Order Hospital Elisabethinen Linz	Linz
Austria	LKH Salzburg, Univ. Clinic	Salzburg
Austria	Wilhelminenspital	Wien
Belgium	Aalst - HOSP Onze-Lieve-Vrouw	Aalst
Belgium	Bonheiden - HOSP Imelda	Bonheiden
Belgium	Brussels - UNIV UZ Brussel	Brussel
Belgium	Brussels-UNIV Brugmann -Horta	Brussel
Belgium	AZ Sint-Lucas - Campus Sint Lucas	Gent
Belgium	Charleroi - HOSP St-Joseph	Gilly
Belgium	Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim	Middelheim
Belgium	Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)	Sint-Niklaas
Belgium	Tienen - PRAC De Wolf, Axel	Tienen
Belgium	Brussels - HOSP Europe (Ste-Elisabeth)	Ukkel
Brazil	Hospital Santa Isabel	Blumenau
Brazil	Irmandade da Santa Casa de Misericordia de Curitiba	Campina Grande do Sul
Brazil	Instituto de Cardiologia Rio Grande do Sul	Porto Alegre
Brazil	Hospital de Base - Fac Med de Sao Jose do Rio Preto	Sao Jose do Rio Preto
Brazil	Hospital Sao Paulo - UNIFESP	Sao Paulo
Brazil	INCOR e Hospital das Clínicas da Universidade de São Paulo	Sao Paulo
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Brazil	Eurolatino pesquisas Médicas Ltda	Uberlandia
Bulgaria	MHAT "Deva Maria", Dept. of Cardiology, Burgas	Burgas
Bulgaria	SHAT in Cardiology EAD, Pleven	Pleven
Bulgaria	MHAT"Sv.Georgi",Cardi.Clin.	Plovdiv
Bulgaria	MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski	Sandanski
Bulgaria	City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia	Sofia
Bulgaria	Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol	Yambol
Canada	Calgary Heart Centre	Calgary	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	CHUS Fleurimont	Sherbrooke	Quebec
Canada	IUCPQ (Laval University)	Ste-Foy	Quebec
Canada	Dr. R. Labonte Prof. Med. Corp	Sudbury	Ontario
Canada	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Chile	Centro de Estudios Clinicos Barros Luco	Santiago
Chile	Hospital San Juan de Dios	Santiago
Chile	Hospital Las Higueras	Talcahuano
Chile	CECMI Ltda	Temuco
Colombia	Fundación Clínica Abood Shaio	Bogotá
Colombia	Fundación Santa Fe de Bogotá	Bogotá
Colombia	Centro Médico Imbanaco de Cali S.A.	Cali
Colombia	Fundación Valle de Lili	Cali
Colombia	Fundación Cardiovascular de Colombia	Floridablanca
Colombia	Hospital Pablo Tobón Uribe	Medellin
Croatia	Clincal Hospital Centre Rijeka	Rijeka
Croatia	Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb	Zagreb
Croatia	Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb	Zagreb
Croatia	University hospital center Zagreb	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Czechia	Amkardia, s.r.o. Brno	Brno
Czechia	Hospital Jihlava	Jihlava
Czechia	Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary	Karlovy Vary
Czechia	University Hospital Olomouc	Olomouc
Czechia	Municipal Hospital Ostrava	Ostrava
Czechia	General Faculty Hospital, Prague	Praha
Czechia	University Hospital Motol	Praha
Czechia	Institute for Clinical and Experimental Medicine	Praha 4
Czechia	Hospital Slany, Internal Department	Slany
Czechia	Hospitals of Pardubice Region, Internal Department, Svitavy	Svitavy
Czechia	Masaryk Hospital, Usti nad Labem	Usti nad Labem
Czechia	Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad	Usti nad Orlici
Denmark	Aarhus Universitetshospital	Århus N
Finland	HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus	Helsinki
Finland	StudyCor Oy	Jyväskylä
Finland	Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola	Kokkola
Finland	TYKS	Turku
France	HOP Ambroise Paré	Boulogne-Billancourt
France	HOP de la Cavale Blanche	Brest Cedex 2
France	HOP Gabriel-Montpied	Clermont-Ferrand
France	HOP CHU de Grenoble	Grenoble
France	HOP St Joseph	Marseille
France	CLI du Pont de Chaume	Montauban
France	HOP Arnaud de Villeneuve	Montpellier cedex 5
France	HOP Pasteur	Nice
France	HOP Lariboisière	Paris
France	HOP Salpêtrière, Cardio, Paris	Paris cedex 13
France	CLI Saint-Hilaire	Rouen
France	HOP Rangueil	Toulouse
Germany	SLK-Kliniken Heilbronn GmbH	Bad Friedrichshall
Germany	Kerckhoff-Klinik, Bad Nauheim	Bad Nauheim
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen	Bad Oeynhausen
Germany	CIMS Studienzentrum Bamberg GmbH	Bamberg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	Vivantes Netzwerk für Gesundheit GmbH	Berlin
Germany	Klinikum Bielefeld gGmbH	Bielefeld
Germany	St. Josef- und St. Elisabeth-Hospital gGmbH	Bochum
Germany	Universitätsklinikum Bonn AöR	Bonn
Germany	Allgemeines Krankenhaus, Celle	Celle
Germany	Klinikum Coburg gGmbH	Coburg
Germany	Helios Amper-Klinikum Dachau	Dachau
Germany	St. Johannes Hospital Dortmund	Dortmund
Germany	Praxisklinik Herz und Gefäße	Dresden
Germany	Städtisches Klinikum Dresden	Dresden
Germany	Evangelisches Krankenhaus Düsseldorf	Düsseldorf
Germany	Agaplesion Markus Krankenhaus	Frankfurt
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Städtisches Klinikum, Fulda	Fulda
Germany	Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem	Göttingen
Germany	Universitätsmedizin Göttingen, Georg-August-Universität	Göttingen
Germany	Cardiologicum Hamburg	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Westküstenkliniken Brunsbüttel und Heide gGmbH	Heide
Germany	HPK-Heidelberger Praxisklinik	Heidelberg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Universitätsklinikum Jena	Jena
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Asklepios Klinik Langen-Seligenstadt GmbH	Langen
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid	Lüdenscheid
Germany	Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen
Germany	Universitätsklinikum Magdeburg AöR	Magdeburg
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Mannheim GmbH	Mannheim
Germany	Carl-von-Basedow Klinikum Saalekreis gGmgH	Merseburg
Germany	Klinikum der Universität München - Campus Großhadern	München
Germany	Städtisches Klinikum München GmbH	München
Germany	Städtisches Klinikum München GmbH	München
Germany	Universitätsklinikum Münster	Münster
Germany	St. Vincenz-Krankenhaus GmbH	Paderborn
Germany	Sana-Klinikum Remscheid GmbH	Remscheid
Germany	Universitätsmedizin Rostock	Rostock
Germany	Robert-Bosch-Krankenhaus GmbH	Stuttgart
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm
Germany	Marien-Hospital-Wesel gGmbH	Wesel
Germany	Helios Universitätsklinikum Wuppertal	Wuppertal
Greece	University Hospital of Alexandroupolis	Alexandroupoli
Greece	General Hospital of Athens "Alexandra"	Athens
Greece	General Hospital of Athens Konstantopoulio-Agia Olga	Athens
Greece	General Hospital of Attica "Sismanoglio - Amalia Fleming"	Athens
Greece	Hippokration Hospital, Univ Clinic of Cardiology	Athens
Greece	General Hospital of Chios, Department of Cardiology	Chios
Greece	University General Hospital of Heraklion	Heraklion, Crete
Greece	Univ. Gen. Hosp. of Ioannina	Ioannina
Greece	University Hospital of Patras	Patras
Greece	University Hospital of Thessaloniki AHEPA	Thessaloniki
Hong Kong	Prince of Wales Hosp, Dept of Med & Therapeutics	Hong Kong
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hungary	Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest	Budapest
Hungary	Milit.Hosp.-State Health Cent.	Budapest
Hungary	Semmelweis University	Budapest
Hungary	University Debrecen Hospital	Debrecen
Hungary	Bacs-Kiskun Megyei Onkormanyzat Hospital	Kecskemet
Hungary	University of Pecs, Invasive Cardiology	Pecs
Hungary	Univ. of Szeged, 2nd Dept. of Internal Med., Haematology	Szeged
India	Care Institute Of Medical Sciences	Ahmedabad
India	Medanta- The Medicity	Gurgaon
India	Nizam's Institute of Medical Sciences	Hyderabad
India	B and M Patel Cardiac Centre, Shree Krishna Hospital,	Karamsad
India	Shri Krishna Hrudayalaya and Critical Care	Nagpur
India	Vijan Cardiac and Critical Care Centre	Nasik
India	Fortis Escorts Heart Institute	New Delhi
India	Byramjee Jeejeebhoy Medical College	Pune
India	King George's Hospital,	Seemandhra
Ireland	Beaumont Hospital	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St James's Hospital	Dublin
Ireland	University Hospital Galway	Galway
Israel	Hillel Yaffe Medical Center, Hadera	Hadera
Israel	Rambam Medical Center	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Shaare Zedek Medical Center, Jerusalem 91031	Jerusalem
Israel	West.Galilee Med.Cent.Naharia	Naharia
Israel	Rabin Medical Center Beilinson	Petah Tikva
Italy	Ospedale San Donato di Arezzo	Arezzo
Italy	ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII	Bergamo
Italy	Fond. Poliambulanza Istituto	Brescia
Italy	A.O.U. Policlinico Vittorio Emanuele	Catania
Italy	Osp. Clin. SS. Anunziata	Chieti
Italy	Ospedale "Fabrizio Spaziani"	Frosinone
Italy	Ospedale della Misericordia	Grosseto
Italy	Azienda Ospedaliera Vito Fazzi	Lecce
Italy	Osp. Pediatrico Aprano Pasquinucci	Massa
Italy	Ospedale Cardarelli	Napoli
Italy	Pol. Universitario Tor Vergata	Roma
Italy	Policlinico Gemelli	Roma
Italy	Presidio Ospedaliero di Saronno	Saronno (VA)
Italy	Ospedale Bolognini	Seriate
Italy	Ospedale Molinette, AO Città della Salute e della	Torino
Japan	Japanese Red Cross Nagoya Daini Hospital	Aichi, Nagoya
Japan	Hirosaki University Hospital	Aomori, Hirosaki
Japan	Chiba University Hospital	Chiba, Chiba
Japan	Kokura Memorial Hospital	Fukuoka, Kitakyushu
Japan	Fukuoka-Higashi Med. Ctr. Fukuoka, CV	Fukuoka, Koga
Japan	Shin Koga Hospital	Fukuoka, Kurume
Japan	Gumma Prefectural Cardiovascular Center	Gunma, Maebashi
Japan	National Hospital Organization Takasaki General Medical Center	Gunma, Takasaki
Japan	Fukuyama Cardiovascular Hospital	Hiroshima, Fukuyama
Japan	National Hospital Organization Hokkaido Medical Center	Hokkaido, Sapporo
Japan	Tokeidai Memorial Hospital	Hokkaido, Sapporo
Japan	Hyogo Brain and Heart Center	Hyogo, Himeji
Japan	The Veritas Hospital	Hyogo, Kawanishi
Japan	Kobe University Hospital	Hyogo, Kobe
Japan	Takahashi Hospital	Hyogo, Kobe
Japan	National Hospital Organization Kanazawa Medical Center	Ishikawa, Kanazawa
Japan	Iwate Medical University Hospital	Iwate, Morioka
Japan	Kagawa Prefectural Central Hospital	Kagawa, Takamatsu
Japan	Shonan Fujisawa Tokushukai Hospital	Kanagawa, Fujisawa
Japan	Kitasato University Hospital	Kanagawa, Sagamihara
Japan	Yokohama City Minato Red Cross Hospital	Kanagawa, Yokohama
Japan	Kyoto University Hospital	Kyoto, Kyoto
Japan	Miyazaki Medical Association Hospital	Miyazaki, Miyazaki
Japan	Osaka City Hospital Organization Osaka City General Hospital	Osaka, Osaka
Japan	Sakurabashi Watanabe Hospital	Osaka, Osaka
Japan	Sayama General Clinic	Saitama, Sayama
Japan	National Hospital Organization Saitama National Hospital	Saitama, Wako
Japan	Kusatsu General Hospital	Shiga, Kusatsu
Japan	Omihachiman Community Medical Center	Shiga, Omihachiman
Japan	Tokushima Red Cross Hospital	Tokushima, Komatsushima
Japan	Nishiarai Heart Center Hospital	Tokyo, Adachi-ku
Japan	Nippon Medical School Hospital	Tokyo, Bunkyo-ku
Japan	Minamino Heart Clinic	Tokyo, Hachioji
Japan	Itabashi Chuo Medical Center	Tokyo, Itabashi-Ku
Japan	Nihon University Itabashi Hospital	Tokyo, Itabashi-Ku
Japan	Teikyo University Hospital	Tokyo, Itabashi-Ku
Japan	Global Health and Medicine Ctr	Tokyo, Shinjuku-ku
Japan	Tokyo Women's Medical University Hospital	Tokyo, Shinjuku-ku
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kyungpook National Univ. Hosp	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Pusan National Univ. Hosp	Pusan
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul
Korea, Republic of	St.Carollo Hospital	Suncheon
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Wonju Severance Christian Hosp	Wonju
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Ciudad de Mexico
Mexico	H. Central Dr Ignacio M. P.	San Luis Potosi
Mexico	Centro Especializado en Terapia Endovascular (CETEN)	Zapopan, Jalisco
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Scheper Ziekenhuis	Emmen
Netherlands	Admiraal de Ruyter Ziekenhuis	Goes
Netherlands	UMCG	Groningen
Netherlands	St. Antonius ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Canisius-Wilhelmina ziekenhuis	Nijmegen
Netherlands	Ziekenhuis Bernhoven Uden	Uden
New Zealand	Waikato Hospital	Hamilton
Norway	Sørlandet sykehus HF, Avd. Arendal	Arendal
Norway	Oslo Universitetssykehus HF, Rikshospitalet	Oslo
Norway	Oslo Universitetssykehus HF, Ullevål sykehus	Oslo
Norway	Stavanger Helseforskning	Stavanger
Norway	Universitetssykehuset Nord-Norge, Tromsø	Tromsø
Poland	Univ. Clinic Hosp, Bialystok	Bialystok
Poland	10.Military Clin.Hospital&Polyclinic	Bydgoszcz
Poland	Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk	Gdansk
Poland	University Clinical Center, Gdansk	Gdansk
Poland	Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce	Kielce
Poland	Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin	Lublin
Poland	Independent Public Healthcare, Dept. of Cardiology, Pulawy	Pulawy
Poland	Central Hospital of Medical Academy, Warsaw	Warsaw
Poland	Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw	Wroclaw
Poland	John Paul II Regional Hospital, Zamosc	Zamosc
Portugal	Hospital Garcia de Orta, EPE	Almada
Portugal	CHUC - Centro Hospitalar e Universitário de Coimbra, EPE	Coimbra
Portugal	Centro Hosp. de Leiria-Pombal	Leiria
Portugal	CHLC, EPE - Hospital de Santa Marta	Lisboa
Portugal	CHLN, EPE - Hospital de Santa Maria	Lisboa
Portugal	CHLO, EPE - Hospital de Santa Cruz	Lisboa
Portugal	CHUC,EPE - Hospital Geral dos Covões	S. Martinho Do Bispo,Coimbra
Russian Federation	Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul	Barnaul
Russian Federation	Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk	Chelyabinsk
Russian Federation	Cent.f.Spec.Med.C.U.Cardi.Inst	Ekaterinburg
Russian Federation	State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan	Kazan
Russian Federation	State Instit.Kazan Fed.Univ.	Kazan
Russian Federation	Res.Inst.-Compl.Iss.Cardi.Dis.	Kemerovo
Russian Federation	Clin.Hosp.#1na S.V.Ochapovskiy	Krasnodar
Russian Federation	City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method	Moscow
Russian Federation	City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow	Moscow
Russian Federation	Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept	Moscow
Russian Federation	City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg	Saint Petersburg
Russian Federation	State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens	Samara
Russian Federation	North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep	St.Petersburg
Russian Federation	State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr	Volgograd
Singapore	National Heart Center	Singapore
Singapore	National University Hospital	Singapore
Slovakia	Slov.Ins.Crdi.Dise.,Cor.C.U.	Banska Bystrica
Slovakia	Nat.Instit.Cardiov.Diseas,Arryhythmias&Cardiac Pacing,Bratis	Bratislava
Slovakia	East Slovak Inst.Cardi.Disea.	Kosice
Slovakia	Kardiocentrum Nitra,Internal Medicine Dept, Nitra	Nitra
Slovenia	General Hospital Celje	Celje
Slovenia	General Hospital Izola, Cardiology Department	Izola
Slovenia	University Medical Center Ljubljana	Ljubljana
Slovenia	Univ. Medical Center Maribor	Maribor
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital de Bellvitge	L'Hospitalet Llobregat (bcn)
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital de Manises	Manises
Spain	CS Parc Taulí	Sabadell (Barcelona)
Spain	Hospital Clínico de Santiago	Santiago de Compostela
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital de Galdakao	Vizcaya
Spain	Hospital Miguel Servet	Zaragoza
Sweden	Länssjukhuset, Gävle	Gävle
Sweden	Sahlgrenska Universitetssjukhuset, Östra	Göteborg
Sweden	Länssjukhuset, Halmstad	Halmstad
Sweden	Lasarettet, Helsingborg	Helsingborg
Sweden	Universitetssjukhuset, Linköping	Linköping
Sweden	Skånes universitetssjukhus, Lund	Lund
Sweden	Skånes universitetssjukhus, Malmö	Malmö
Sweden	Danderyds Sjukhus	Stockholm
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	NCKUH	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipe Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital(TaoYuan)	Taoyuan
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Thailand	Srinagarind Hospital	Khon Kaen
Turkey	Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali	Adana
Turkey	Diskapi Yildirim Beyazit EAH	Ankara
Turkey	Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Ankara
Turkey	Bursa Yuksek Ihtisas EAH	Bursa
Turkey	Bagcilar Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi	Istanbul
Turkey	Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Istanbul Universitesi Kardiyoloji Enstitusu	Istanbul
Turkey	Kartal Kosuyolu Yuksek Ihtisas EAH	Istanbul
Turkey	Medipol Mega Üniversitesi Hastanesi	Istanbul
Turkey	Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi	Istanbul
Turkey	Dokuz Eylul Unv. Tip Fakultesi	Izmir
Turkey	Izmir Katip Celebi Univ. EAH	Izmir
Turkey	Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali	Kayseri
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi	Samsun
United Kingdom	Birmingham City Hospital	Birmingham
United Kingdom	Royal Bournemouth and Christchurch Hospital	Bournemouth
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Dorset County Hospital	Dorchester
United Kingdom	Grantham District Hospital	Grantham
United Kingdom	Wycombe General Hospital	High Wycombe
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Lincoln County Hospital	Lincoln
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Altnagelvin Area Hospital	Londonderry
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent
United States	Community Clinical Research Center	Anderson	Indiana
United States	Aurora Denver Cardiology Associates, PC	Aurora	Colorado
United States	Cardiology P.C.	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	VA Western New York Healthcare System	Buffalo	New York
United States	Chambersburg Hospital	Chambersburg	Pennsylvania
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	Chattanooga Heart Institute	Chattanooga	Tennessee
United States	Verde Valley Medical Center	Cottonwood	Arizona
United States	Dallas VA Medical Center	Dallas	Texas
United States	Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center	Duluth	Minnesota
United States	Midwest Cardiovascular Research and Education Foundation	Elkhart	Indiana
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Altru Health System	Grand Forks	North Dakota
United States	Pinnacle Health Harrisburg Hospital	Harrisburg	Pennsylvania
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Cape Cod Research Institute	Hyannis	Massachusetts
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	University of Florida College of Medicine	Jacksonville	Florida
United States	Kansas City Veterans Administration Medical Center	Kansas City	Missouri
United States	Watson Clinic, LLP	Lakeland	Florida
United States	Arkansas Cardiology, PA	Little Rock	Arkansas
United States	Holy Family Memorial, Inc	Manitowoc	Wisconsin
United States	North Dallas Research Associates	McKinney	Texas
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	Mid Michigan Medical Center	Midland	Michigan
United States	Ball Memorial Hospital	Muncie	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	St. Michaels Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Richmond Cardiology Associates Research, LLC	Richmond	Indiana
United States	Scott and White Healthcare	Round Rock	Texas
United States	Covenant Medical Center, Inc.	Saginaw	Michigan
United States	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota
United States	Saint Anthony's Medical Center	Saint Louis	Missouri
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	South Texas Cardiovascular Consultants	San Antonio	Texas
United States	HonorHealth Research Institute	Scottsdale	Arizona
United States	Cardiovascular Research Center	Toledo	Ohio
United States	Bayview Physicians Services PC dba Cardiovascular Associates	Virginia Beach	Virginia
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Wichita Falls Heart Clinic	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  Slovenia,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Adjudicated ISTH MBE or CRNMBE	Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.; Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.; Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.; Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.	up to 30 months
Secondary	Time to Adjudicated Undetermined Cause of Death	Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.; This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.	up to 30 months
Secondary	Time to Adjudicated Non-CV	Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.; Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV	up to 30 months
Secondary	Time to Adjudicated CV	Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.; CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.	up to 30 months
Secondary	Time to Adjudicated All Cause Death	Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.	up to 30 months
Secondary	Time to First Adjudicated MI	Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported	up to 30 months
Secondary	Time to First Adjudicated Stroke	Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.; Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction	up to 30 months
Secondary	Time to First Adjudicated SE	Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.; SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.	up to 30 months
Secondary	Time to First Adjudicated ST	Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.	up to 30 months
Secondary	Time to Composite Endpoint of Death + MI + Stroke	Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.	up to 30 months
Secondary	Time to Composite Endpoint of Death or First Thrombotic Event	Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).	up to 30 months
Secondary	Time to First Adjudicated Unplanned Revascularisation by PCI/CABG	Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.	up to 30 months
Secondary	Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG	Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.	up to 30 months

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