Stroke Clinical Trial
Official title:
Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Verified date | August 2019 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).
Status | Completed |
Enrollment | 5390 |
Est. completion date | August 14, 2018 |
Est. primary completion date | August 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 150 Years |
Eligibility |
Inclusion criteria: - Ischemic stroke with a brain lesion visualized by neuroimaging (either brain Computed Tomography (CT) or Magnetic Resonance Image (MRI)). The visualized stroke is a non-lacunar infarct , e.g. involving the cortex or >1.5 cm (>2.0 cm if measured on MRI diffusion-weighted images) in largest diameter if exclusively subcortical.Visualization by CT usually requires delayed imaging >24-48 hours after stroke onset. - The index stroke must have occurred either up to 3 months before randomization (Modified Rankin Scale(mRS) <=3 at randomization) or up to 6 months before randomization (mRS <=3 at randomization) in selected patients that are >= 60 years plus at least one additional risk factor for recurrent stroke. - Arterial imaging or cervical plus Transcranial Doppler (TCD) ultrasonography does not show extra-cranial or intracranial atherosclerosis with >= 50% luminal stenosis in artery supplying the area of acute ischemia. - As evidenced by cardiac monitoring for >= 20 hours with automated rhythm detection, there is absence of AF > 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes). Further inclusion criteria apply. Exclusion criteria: - Modified Rankin Scale of >=4 at time of randomization or inability to swallow medications. - Major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent Atrial fibrillation (AF), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis. - Any indication that requires treatment with an anticoagulant as per Investigator`s judgment. - History of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved). - Other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse). - Renal impairment with estimated creatinine clearance (as calculated by Cockcroft-Gault equation) <30mL/min at screening, or where Investigator expects creatinine clearance is likely to drop below 30mL/min during the course of the study. Further exclusion criteria apply. |
Country | Name | City | State |
---|---|---|---|
Argentina | Fundación Favaloro | Caba | |
Argentina | Hospital Italiano de Buenos Aires | Caba | |
Argentina | STAT Research | Caba | |
Argentina | Instituto Médico DAMIC S.R.L. | Cordoba | |
Argentina | Clinica Coronel Suarez SA | Coronel Suarez | |
Argentina | Hospital Privado de Comunidad | Mar del Plata | |
Australia | Calvary North Adelaide Hospital | Adelaide | South Australia |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Sunshine Coast University Hospital | Birtinya | Queensland |
Australia | Box Hill Hospital | Box Hill | Victoria |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Kanwal Medical Complex | Kanwal | New South Wales |
Australia | John Hunter Hospital | New Lambton | New South Wales |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
Australia | Alfred Health | Victoria | |
Austria | LKH-Univ. Hospital Graz | Graz | |
Austria | Medical University of Innsbruck | Innsbruck | |
Austria | Kepler Univ. Klinikum Linz | Linz | |
Austria | Kepler Univ. Klinikum Linz | Linz | |
Austria | KH d. Barmherzigen Brüder Linz, Neurologie | Linz | |
Austria | Universitätsklinikum Tulln, Abteilung für Neurologie | Tulln | |
Austria | Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien | Vienna | |
Austria | Wilhelminenspital | Wien | |
Belgium | Aalst - HOSP Onze-Lieve-Vrouw | Aalst | |
Belgium | Arlon - HOSP Sud Luxembourg - Vivalia | Arlon | |
Belgium | AZ Sint-Jan Brugge | Brugge | |
Belgium | Brussels - HOSP Europe (Ste-Elisabeth) | Brussel | |
Belgium | Brussels-UNIV Brugmann -Horta | Brussel | |
Belgium | Brussels - UNIV Saint-Luc | Bruxelles | |
Belgium | UNIV UZ Gent | Gent | |
Belgium | Kortrijk - HOSP AZ Groeninge Kennedylaan | Kortrijk | |
Belgium | UZ Leuven | Leuven | |
Belgium | Liège - HOSP St-Joseph | Liège | |
Belgium | Roeselare - HOSP AZ Delta | Roeselare | |
Belgium | Rumst - HOSP AZ Heilige Familie | Rumst | |
Belgium | Sint-Truiden - HOSP St-Trudo (St-Jozef) | Sint-Truiden | |
Belgium | Wilrijk - HOSP GZA (St-Augustinus) | Wilrijk | |
Belgium | Yvoir - UNIV UCL de Mont-Godinne | Yvoir | |
Brazil | Hospital Clinicas de Botucatu | Botucatu | |
Brazil | Instituto de Medicina Flumignano | Curitiba | |
Brazil | Clinica Neurologica e Neurocirurgica de Joinvile | Joinvile | |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | |
Brazil | H.C.da Fac. de Medicina de Ribeirao Preto | Ribeirao Preto | |
Brazil | Hospital Quinta D¿Or | Rio de Janeiro | |
Canada | Prairie Mountain Health | Brandon | Manitoba |
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | CSSS de Chicoutimi | Chicoutimi | Quebec |
Canada | Grey Nuns Hospital | Edmonton | Alberta |
Canada | University of Alberta Hospital (University of Alberta) | Edmonton | Alberta |
Canada | Hopital Charles - LeMoyne | Greenfield Park | Quebec |
Canada | Victoria Hospital (LHSC) | London | Ontario |
Canada | Hopital Notre-Dame du CHUM | Montreal | Migration Data |
Canada | Jewish General Hospital | Montreal | Migration Data |
Canada | Montreal General Hospital - McGill University Health Centre | Montreal | Quebec |
Canada | CHU de Quebec-Universite Laval Research Centre | Quebec | |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Canada | CHUS Fleurimont | Sherbrooke | Quebec |
Canada | St Jerome Medical Research Inc. | St-Jerome | Quebec |
Canada | Eastern Health (MUN) | St. John's | Newfoundland and Labrador |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Toronto Western Hospital | Toronto | Ontario |
Chile | Clínica Alemana de Santiago S.A. | Santiago | |
Chile | Clínica Dávila | Santiago | |
Chile | Clinica Alemana de Temuco | Temuco | |
China | Beijing Tiantan Hospital affiliated to Cap Med University | Beijing | |
China | Peking University Third Hospital | Beijing | |
China | First Hospital of Jilin University | Changchun | |
China | First Affiliated Hospital of Guangzhou Medical University | Guangzhou | |
China | First Affiliated Hospital of Guangzhou University of TCM | Guangzhou | |
China | The First Affiliated Hospital of Jinan University | Guangzhou | |
China | The Affiliated Hospital of Guizhou Medical University | Guiyang | |
China | 2nd Affiliated Hosp Zhejiang University College of Medical | Hangzhou | |
China | The Affiliated Hospital of Hangzhou Normal University | Hangzhou | |
China | Zhejiang Hospital | Hangzhou | |
China | Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital | Hangzhou | |
China | Jinlin Central Hospital | Jilin | |
China | The Second Affiliated Hospital to Nanchang University | Nanchang | |
China | Nanjing Drum Tower Hospital | Nanjing | |
China | Zhongda Hospital Southeast University | Nanjing | |
China | QingDao Municipal Hospital | Qingdao | |
China | The affiliated hospital of medicalcollege qingdao university | Qingdao | |
China | Huashan Hospital, Fudan University | Shanghai | |
China | Tongji Hospital, Tongji University | Shanghai | |
China | General Hospital of Shenyang Military Region | Shenyang | |
China | First Affiliated Hospital of Xiamen University | Xiamen | |
China | Affiliated Hospital, Xuzhou Medical college | Xuzhou | |
Colombia | Servicios Médicos Muñoz Solano | Bogotá | |
Colombia | Sociedad de Cirugia de Bogota Hospital de San José | Bogotá | |
Colombia | Fundación Valle del Lili | Cali | |
Colombia | Fundación Cardiovascular de Colombia | Floridablanca | |
Croatia | General Hospital Varazdin | Varazdin | |
Croatia | Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care | Zagreb | |
Croatia | Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb | Zagreb | |
Croatia | University hospital center Zagreb | Zagreb | |
Czechia | Cerebrovascular site, private prac., Brno | Brno | |
Czechia | Hospital Jihlava | Jihlava | |
Czechia | University Hospital Olomouc | Olomouc | |
Czechia | Cerebrovascular site, Ostrava | Ostrava | |
Czechia | Cerebrovascular site, Ostrava | Ostrava | |
Czechia | Hospital Homolka, Prague | Prague 5 | |
Czechia | University Hospital Motol | Praha 5 | |
Estonia | East Estonia Central Hospital, Neurology Dept, Ahtme | Ahtme | |
Estonia | North Estonia Medical Centre Foundation, Tallin | Tallinn | |
Estonia | West Tallinn Central Hospital, Neurology Dept. | Tallinn | |
Estonia | Tartu University Hospital | Tartu | |
France | HOP Pays d'Aix | Aix en Provence | |
France | HOP de Bayonne | Bayonne | |
France | HOP Jean Minjoz | Besançon | |
France | HOP Pellegrin | Bordeaux | |
France | HOP de la Cavale Blanche | Brest | |
France | HOP Pierre Wertheimer | Bron | |
France | HOP Côte de Nacre | Caen | |
France | HOP Grenoble, Neuro, Grenoble | Grenoble | |
France | HOP Roger Salengro | Lille | |
France | HOP Mercy | Metz | |
France | GHU Paris Psychiatrie et Neurosciences | Paris | |
France | HOP Paris Saint-Joseph | Paris | |
France | HOP Purpan | Toulouse | |
Germany | Klinikum Altenburger Land GmbH | Altenburg | |
Germany | Neurologische Klinik GmbH, Bad Neustadt | Bad Neustadt | |
Germany | Vivantes Netzwerk für Gesundheit GmbH | Berlin | |
Germany | Evangelisches Klinikum Bethel gGmbH | Bielefeld | |
Germany | Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH | Bochum | |
Germany | St. Josef- und St. Elisabeth-Hospital gGmbH | Bochum | |
Germany | Gesundheit Nord gGmbH | Klinikverbund Bremen | Bremen | |
Germany | Klinikum Bremerhaven | Bremen | |
Germany | Krankenhäuser Buchholz und Winsen gGmbH | Buchholz | |
Germany | Allgemeines Krankenhaus, Celle | Celle | |
Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
Germany | Klinikum Coburg gGmbH | Coburg | |
Germany | Klinikzentrum Mitte, Dortmund | Dortmund | |
Germany | Städtisches Klinikum Dresden | Dresden | |
Germany | Universitätsklinikum Carl Gustav Carus Dresden | Dresden | |
Germany | Marien-Hospital, Düsseldorf | Düsseldorf | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | Universitätsklinikum Erlangen | Erlangen | |
Germany | Alfried Krupp Krankenhaus Essen | Essen | |
Germany | Universitätsklinikum Essen AöR | Essen | |
Germany | Klinikum Frankfurt Höchst GmbH | Frankfurt | |
Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | |
Germany | Klinikum Friedrichshafen | Friedrichshafen | |
Germany | Klinikum Fulda gAG | Fulda | |
Germany | Evangelische Klinik Gelsenkirchen | Gelsenkirchen | |
Germany | SRH Wald-Klinikum Gera GmbH | Gera | |
Germany | Universitätsklinikum Gießen und Marburg GmbH | Gießen | |
Germany | Universitätsmedizin Greifswald | Greifswald | |
Germany | Bezirkskrankenhaus, Günzburg | Günzburg | |
Germany | Asklepios Klinik Altona | Hamburg | |
Germany | Asklepios Klinik Barmbek | Hamburg | |
Germany | Asklepios Klinik Harburg | Hamburg | |
Germany | Asklepios Klinik St. Georg | Hamburg | |
Germany | Asklepios Klinik Wandsbek | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Klinikum Hanau GmbH | Hanau | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | SLK-Kliniken Heilbronn GmbH | Heilbronn | |
Germany | Klinikum Idar-Oberstein | Idar-Oberstein | |
Germany | Universitätsklinikum Jena | Jena | |
Germany | Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | |
Germany | Universitätsklinikum Köln (AöR) | Köln | |
Germany | Universitätsklinikum Leipzig | Leipzig | |
Germany | Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | |
Germany | Universitätsklinikum Magdeburg AöR | Magdeburg | |
Germany | Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | |
Germany | Universitätsklinikum Gießen und Marburg GmbH | Marburg | |
Germany | Elblandklinikum Meißen | Meißen | |
Germany | Johannes Wesling Klinikum | Minden | |
Germany | Kliniken Maria Hilf GmbH | Moenchengladbach | |
Germany | Ökumenisches Hainich Klinikum gGmbH | Mühlhausen | |
Germany | Klinikum der Universität München - Campus Großhadern | München | |
Germany | Klinikum rechts der Isar der Technischen Universität München | München | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Klinikum Nürnberg | Nürnberg | |
Germany | Sana Klinikum Offenbach GmbH | Offenbach | |
Germany | Klinikum Osnabrück GmbH | Osnabrück | |
Germany | Universitätsklinikum Regensburg | Regensburg | |
Germany | Nordwest-Krankenhaus Sanderbusch gGmbH | Sande | |
Germany | Kreisklinikum Siegen GmbH | Siegen | |
Germany | Bürgerhospital, Stuttgart | Stuttgart | |
Germany | Nervenklinik Teupitz, Teupitz | Teupitz | |
Germany | Krankenhaus der Barmherzigen Brüder Trier | Trier | |
Germany | Universitätsklinikum Tübingen | Tübingen | |
Germany | RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH | Ulm | |
Germany | Sophien- und Hufeland-Klinikum gGmbH | Weimar | |
Germany | Helios Dr. Horst Schmidt Kliniken Wiesbaden | Wiesbaden | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Greece | Univ.Hosp. of Alexandroupolis | Alexandroupolis | |
Greece | Attikon University Hospital | Athens | |
Greece | Gen.Hosp.of Ath.Evangelismos | Athens | |
Greece | Gen.Univ. Hosp. of Herakleion | Herakleion | |
Greece | General University Hospital of Larissa | Larissa | |
Greece | Univ. Gen. Hosp. of Patras | Patras | |
Greece | Univ.Gen.Hosp. of Thessaloniki | Thessaloniki | |
Hong Kong | Pamela Youde Nethersole Eastern Hospital | Hong Kong | |
Hong Kong | Prince of Wales Hospital | Hong Kong | |
Hong Kong | Queen Mary Hospital | Hong Kong | |
Hungary | National Instit.of Neurosciences,Neurology Dept,Budapest | Budapest | |
Hungary | Semmelweis University | Budapest | |
Hungary | Univ. Debrecen Medical Health Science Center, Neurology Dept | Debrecen | |
Hungary | Pest Megyei Flor Ferenc Hospital | Kistarcsa | |
Hungary | CRU Hungary Ltd, Private Practice, Miskolc | Miskolc | |
Hungary | Univ. of Pecs Clinic for Neurology | Pecs | |
India | St. Johns medical College and Hospital | Bangalore | |
India | Post Graduate Institute of Medical Education and Research | Chandigarh | |
India | Lalitha Super Specialities Hospital | Guntur | |
India | Nizam's Institute of Medical Sciences | Hyderabad | |
India | Shree Krishna Hospital and Research Centre | Karamsad | |
India | Caritas Hospital | Kottayam | |
India | Mangala Hospital and Mangala Kidney Foundation | Mangalore | |
India | LTMMC & GH Medical College, | Mumbai | |
India | Magnum Heart Institute | Nashik | |
India | All India Institute of Medical Sciences | New Delhi | |
India | Sahyadri Speciality Hospital | Pune | |
Israel | Hillel Yaffe Medical Center, Hadera | Hadera | |
Israel | Wolfson Medical Center | Holon | |
Israel | The Chaim Sheba Medical Center Tel Hashomer | Tel Hashomer, Ramat Gan | |
Israel | Sourasky Medical Center | Telaviv | |
Italy | Osp. SS Filippo Nicola | Avezzano | |
Italy | Policlinico S. Orsola Malpighi | Bologna | |
Italy | A.O. Spedali Civili di Brescia | Brescia | |
Italy | Azienda Ospedaliero Universitaria di Ferrara | Cona (FE) | |
Italy | Policlinico San Martino | Genova | |
Italy | A.O.U.Policlinico G.Martino | Messina | |
Italy | Fondazione Centro San Raffaele del Monte Tabor | Milano | |
Italy | Istituto Auxologico Italiano | Milano | |
Italy | Nuovo Ospedale Civile S. Agostino-Estense | Modena | |
Italy | Azienda Ospedaliera Universitaria di Padova | Padova | |
Italy | Ospedale S.Maria della Misericordia, AO di Perugia | Perugia | |
Italy | Osp. Guglielmo da Saliceto AUSL di Piacenza | Piacenza | |
Italy | Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese | Pietra Ligure | |
Italy | A.O. San Camillo Forlanini | Roma | |
Italy | Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | |
Italy | Umberto I Pol. di Roma-Università di Roma La Sapienza | Roma | |
Italy | Università degli Studi Campus Bio-Medico | Roma | |
Italy | A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | |
Italy | Ospedale Maria Vittoria | Torino | |
Italy | Ospedale Molinette, AO Città della Salute e della | Torino | |
Italy | Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO | Treviso | |
Italy | A. O. Ospedale Circolo Fond. Macchi | Varese | |
Italy | Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona | Verona | |
Japan | Chubu Rosai Hospital | Aichi, Nagoya | |
Japan | National Hospital Organization Toyohashi Medical Center | Aichi, Toyohashi | |
Japan | Toyota Memorial Hospital | Aichi, Toyota | |
Japan | Reserch Institute for Brain and Blood Vessels Akita | Akita, Akita | |
Japan | Juntendo University Urayasu Hospital | Chiba, Urayasu | |
Japan | Go Neurosurgical Clinic | Fukuoka, Chikushi-gun | |
Japan | Fukuoka University Chikushi Hospital | Fukuoka, Chikushino | |
Japan | Fukuoka University Hospital | Fukuoka, Fukuoka | |
Japan | Fukuoka Wajiro Hospital | Fukuoka, Fukuoka | |
Japan | National Hospital Organization Kyushu Medical Center | Fukuoka, Fukuoka | |
Japan | Fukuoka Tokushukai Medical Center | Fukuoka, Kasuga | |
Japan | Japan Community Health Care Organization Kyushu Hospital | Fukuoka, Kitakyushu | |
Japan | Steel Memorial Yawata Hospital | Fukuoka, Kitakyushu | |
Japan | Shin Koga Hospital | Fukuoka, Kurume | |
Japan | St. Mary's Hospital | Fukuoka, Kurume | |
Japan | Fukuoka Shin Mizumaki Hospital | Fukuoka, Onga | |
Japan | Social Insurance Tagawa Hospital | Fukuoka, Tagawa | |
Japan | Shin Yukuhashi Hospital | Fukuoka, Yukuhashi | |
Japan | Fujita General Hospital | Fukushima, Date-Gun | |
Japan | Shinseikai Masu Memorial Hospital | Fukushima, Nihonmatsu | |
Japan | Asahi University Hospital | Gifu, Gifu | |
Japan | Japanese Red Cross Takayama Hospital | Gifu, Takayama | |
Japan | Mihara Memorial Hospital | Gunma, Isesaki | |
Japan | Maebashi Red Cross Hospital | Gunma, Maebashi | |
Japan | Araki Neurosurgical Hospital | Hiroshima, Hiroshima | |
Japan | Hiroshima Prefectural Hospital | Hiroshima, Hiroshima | |
Japan | Medical corporation Suiseikai Suiseikai Kajikawa Hospital | Hiroshima, Hiroshima | |
Japan | Nakamura Memorial Hospital | Hokkaido, Sapporo | |
Japan | Sapporo Shiroishi Memorial Hospital | Hokkaido, Sapporo | |
Japan | Kobe City Medical Center General Hospital | Hyogo, Kobe | |
Japan | JA Toride Medical Center | Ibaraki, Toride | |
Japan | Tsukuba Medical Center Hospital | Ibaraki, Tsukuba | |
Japan | Iwate Medical University Hospital | Iwate, Morioka | |
Japan | Kagoshima City Hospital | Kagoshima, Kagoshima | |
Japan | National Hospital Organization Kagoshima Medical Center | Kagoshima, Kagoshima | |
Japan | Shonan Kamakura General Hospital | Kanagawa, Kamakura | |
Japan | Japanese Red Cross Kumamoto Hospital | Kumamoto, Kumamoto | |
Japan | Kumamoto City Hospital | Kumamoto, Kumamoto | |
Japan | Saiseikai Kumamoto Hospital | Kumamoto, Kumamoto | |
Japan | Uji-Tokushukai Medical Center | Kyoto, Uji | |
Japan | National Hospital Organization Sendai Medical Center | Miyagi, Sendai | |
Japan | South Miyagi Medical Center | Miyagi, Shibata-gun | |
Japan | Ina Central Hospital | Nagano, Ina | |
Japan | Nagano Municipal Hospital | Nagano, Naganoi | |
Japan | Nagasaki University Hospital | Nagasaki, Nagasaki | |
Japan | Nozaki Tokushukai Hospital | Osaka, Daito | |
Japan | Higashiosaka City Medical Center | Osaka, Higashiosaka | |
Japan | Wakakusa Daiichi Hospital | Osaka, Higashiosaka | |
Japan | Rinku General Medical Center | Osaka, Izumisano | |
Japan | Kishiwada Tokushukai Hospital | Osaka, Kishiwada | |
Japan | Tominaga Hospital | Osaka, Osaka | |
Japan | Yagi Neurosurgical Hospital | Osaka, Osaka | |
Japan | Osaka University Hospital | Osaka, Suita | |
Japan | TMG Asaka Medical Center | Saitama, Asaka | |
Japan | Saitama Medical University International Medical Center | Saitama, Hidaka | |
Japan | Sainokuni Higashiomiya Medical Center | Saitama, Saitama | |
Japan | Saitama Municipal Hospital | Saitama, Saitama | |
Japan | Nippon Medical School Hospital | Tokyo, Bunkyo-ku | |
Japan | Tokyo Metropolitan Geriatric Hospital | Tokyo, Itabashi-ku | |
Japan | Kyorin University Hospital | Tokyo, Mitaka | |
Japan | Tokyo Women's Medical University Hospital | Tokyo, Shinjuku-ku | |
Japan | Saiseikai Wakayama Hospital | Wakayama, Wakayama | |
Japan | Yamagata City Hospital SAISEIKAN | Yamagata, Yamagata | |
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | |
Korea, Republic of | Dong-A University Hospital | Busan | |
Korea, Republic of | Kyungpook National Univ. Hosp | Daegu | |
Korea, Republic of | Chungnam National University Hospital | Daejoen | |
Korea, Republic of | Inje University Ilsan Paik Hospital | Goyang | |
Korea, Republic of | Chonnam National University Hospital | Gwangju | |
Korea, Republic of | Chosun University Hospital | Gwangju | |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Chung-Ang University Hospital | Seoul | |
Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Severance Hospital | Seoul | |
Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | |
Korea, Republic of | Ajou University Hospital | Suwon | |
Malaysia | Sarawak General Hospital | Kuching | |
Malaysia | Hospital Seberang Jaya | Pulau Pinang | |
Malaysia | Hospital Sultanah Nur Zahirah | Terengganu | |
Mexico | Hospital General de Culiacán "Dr. Bernardo J. Gastellum" | Culiacán | |
Mexico | Hospital Angeles del Pedregal | México, D.F. | |
Mexico | Hospital General "Dr. Miguel Silva" | Morelia | |
Mexico | Hospital Universitario Dr Jose Eleuterio Gonzalez | Nuevo Leon | |
Mexico | H. Central Dr Ignacio M. P. | San Luis Potosi | |
New Zealand | Auckland City Hospital | Grafton / Auckland | |
New Zealand | North Shore Hospital, Takapuna | Takpuna Auckland | |
New Zealand | Wellington Hospital | Wellington | |
Peru | Instituto Nacional de Ciencias Neurológicas | Barrios Altos | |
Peru | Hospital Nacional Guillermo Almenara Irigoyen | La Victoria | |
Poland | PI HOUSE Sp. z o.o., Gdansk | Gdansk | |
Poland | Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz | Grudziadz | |
Poland | Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice | Katowice | |
Poland | Center of Clinical Neurology, private prac, Krakow | Krakow | |
Poland | University Hospital in Krakow | Krakow | |
Poland | Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin | Lublin | |
Poland | Medicome Sp. z o.o. | Oswiecim | |
Poland | Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz | Sandomierz | |
Poland | Military Institute of Medicine Neurology Clinic, Warsaw | Warsaw | |
Poland | Public Central Clinical Hosp,Neurology Clinic,Warsaw | Warsaw | |
Portugal | Hospital Garcia de Orta, EPE | Almada | |
Portugal | Hospital Fernando Fonseca, EPE | Amadora | |
Portugal | Hospital de Braga - Centro Clínico Académico (2CA) | Braga | |
Portugal | CHUC - Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra | |
Portugal | CHLC, EPE - Hospital de São José | Lisboa | |
Portugal | CHLO, EPE - Hospital Egas Moniz | Lisboa | |
Portugal | CHULN, EPE - Hospital de Santa Maria | Lisboa | |
Portugal | Hospital Beatriz Ângelo | Loures | |
Portugal | USLM, EPE - Hospital Pedro Hispano | Matosinhos | |
Portugal | Centro Hospitalar São João,EPE | Porto | |
Portugal | H. Santo António - Centro Hospitalar do Porto | Porto | |
Portugal | Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião | Santa Maria da Feira | |
Russian Federation | Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan | Kazan | |
Russian Federation | Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar | Krasnodar | |
Russian Federation | City Clin.Emergency Hosp of Kursk, Neurology Department No.2 | Kursk | |
Russian Federation | City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow | Moscow | |
Russian Federation | CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow | Moscow | |
Russian Federation | Clin.Hosp#2,na.Semashko,Russ.Railways,Restorative Med&Rehab. | Moscow | |
Russian Federation | Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow | Moscow | |
Russian Federation | Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk | Novosibirsk | |
Russian Federation | Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin | Saratov | |
Russian Federation | Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology | Smolensk | |
Russian Federation | Military Medical Academy n.a. C. M. Kirov, St. Petersburg | St. Petersburg | |
Russian Federation | Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg | St. Petersburg | |
Russian Federation | Sverdlovsk Reg.Clin.Hosp.No.1 | Yekaterinburg | |
Serbia | Clinical Center of Serbia | Belgrade | |
Serbia | Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade | Belgrade | |
Serbia | Clinical Centre Nis | Nis | |
Serbia | Clinical Center of Vojvodina | Novi Sad | |
Singapore | National Neuroscience Institute | Singapore | |
Singapore | National University Hospital | Singapore | |
Singapore | Singapore General Hospital | Singapore | |
Slovakia | Faculty Hospital L. Pasteura, Kosice | Kosice | |
Slovakia | Faculty Hospital Nitra | Nitra | |
Slovenia | Instit.f.applicative Research in med.rehab.Dobrna | Dobrna | |
Slovenia | Cardial d.o.o., Specialist out-patient unit, Ljubljana | Ljubljana | |
Slovenia | Univ. Medical Center Maribor | Maribor | |
South Africa | University of Pretoria | Pretoria | |
South Africa | Dr. Moodley and Dr. Sarvan | Tongaat | |
Spain | Hospital General Universitario de Albacete | Albacete | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital Universitari de Girona Doctor Josep Trueta | Girona | |
Spain | Hospital Arnau de Vilanova | Lleida | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
Spain | Hospital La Paz | Madrid | |
Spain | Hospital La Princesa | Madrid | |
Spain | Hospital Ramón y Cajal | Madrid | |
Spain | Hospital Son Espases | Palma de Mallorca | |
Spain | Complejo Hospitalario de Navarra | Pamplona | |
Spain | Hospital Universitario Donostia | San Sebastian | |
Spain | Hospital Clínico de Santiago | Santiago de Compostela | |
Spain | Hospital Virgen del Rocío | Sevilla | |
Spain | Hospital Universitari Joan XXIII | Tarragona | |
Spain | Hospital Mútua Terrassa | Tarrasa (Barcelona) | |
Spain | Hospital Clínico de Valencia | Valencia | |
Spain | Hospital Clínico Universitario de Valladolid | Valladolid | |
Sweden | Sahlgrenska Universitetssjukhuset, Östra | Göteborg | |
Sweden | Sahlgrenska US, Göteborg | Göteborg | |
Sweden | Skaraborgs Sjukhus | Skövde | |
Sweden | Danderyds Sjukhus | Stockholm | |
Sweden | Karolinska Univ. sjukhuset | Stockholm | |
Sweden | Karolinska Univ. sjukhuset | Stockholm | |
Switzerland | Canton Hospital Aarau, Neurology Dept., Stroke Center | Aarau | |
Switzerland | University Hospital Basel | Basel | |
Switzerland | Univ. Hospital Bern, Neurology Dept, Stroke Center | Bern | |
Switzerland | CHUV - Centre hospitalier universitaire vaudois | Lausanne | |
Switzerland | Regional Hospital Lugano,Neurocenter of Southern Switzerland | Lugano | |
Switzerland | Kantonsspital St.Gallen | St. Gallen | |
Switzerland | University Hosp. Zürich, Dept. of Neurology, Stroke Center | Zürich | |
Taiwan | Chang-Hua Christian Hospital | Changhua | |
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | |
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | Taichung Veterans General Hospital | Taichung | |
Taiwan | NCKUH | Tainan | |
Taiwan | Chi Mei Medical Center | Tainan, | |
Taiwan | Cheng Hsin General Hospital | Taipei | |
Taiwan | Mackay Memorial Hospital | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipe Veterans General Hospital | Taipei | |
Taiwan | Tri-Service General Hospital | Taipei | |
Taiwan | Chang Gung Memorial Hospital(TaoYuan) | Taoyuan | |
Thailand | Chulalongkorn University | Bangkok | |
Thailand | Ramathibodi Hospital | Bangkok | |
Thailand | Siriraj Hospital | Bangkok | |
Thailand | Lampang Hospital | Lampang | |
Turkey | Ankara Universitesi Tip Fakultesi | Ankara | |
Turkey | Gazi Universitesi Tip Fakultesi | Ankara | |
Turkey | Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D. | Ankara | |
Turkey | Eskisehir Osmangazi Universitesi Tip Fakultesi | Eskisehir | |
Turkey | Bakirkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi | Istanbul | |
Turkey | Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari | Istanbul | |
Turkey | Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi | Istanbul | |
Turkey | Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | |
Turkey | Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D. | Istanbul | |
Turkey | Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi | Istanbul | |
Turkey | Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi | Istanbul | |
Turkey | Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D. | Izmir | |
Turkey | Ondokuz Mayis Universitesi Tip Fakultesi | Samsun | |
Turkey | Namik Kemal Universitesi Tip Fakultesi | Tekirdag | |
Ukraine | Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog | Chernivtsi | |
Ukraine | City Clinical Hospital No. 7, Kharkov | Kharkiv | |
Ukraine | Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep | Kharkiv | |
Ukraine | Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path. | Kyiv | |
Ukraine | Lviv Regional Clinical Hospital, Lviv | Lviv | |
Ukraine | Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3 | Ternopil | |
Ukraine | Vinnitsia Reg.Psychoneurol.Hosp.na Yushchenko,Dept.N3,Neurol | Vinnitsia | |
Ukraine | Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep | Zhytomyr | |
United States | Alexandria Cardiology Clinic | Alexandria | Louisiana |
United States | Community Clinical Research Center | Anderson | Indiana |
United States | Anne Arundel Medical Center | Annapolis | Maryland |
United States | Northwest Heart Clinical Research, LLC | Arlington Heights | Illinois |
United States | JEM Research Institute | Atlantis | Florida |
United States | Augusta University | Augusta | Georgia |
United States | University of Colorado Denver | Aurora | Colorado |
United States | Seton Medical Center Austin | Austin | Texas |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Westside Medical Associates of Los Angeles | Beverly Hills | California |
United States | Boca Raton Regional Hospital | Boca Raton | Florida |
United States | Saint Alphonsus Medical Center-Neurology | Boise | Idaho |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Tenet Florida Physician Services | Boynton Beach | Florida |
United States | Nova Clinical Research, LLC | Bradenton | Florida |
United States | NYC Health + Hospitals/Coney Island | Brooklyn | New York |
United States | University of Vermont | Burlington | Vermont |
United States | Novant Health Neurology Specialists | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Boone Hospital Center | Columbia | Missouri |
United States | University of Missouri Health System | Columbia | Missouri |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | New York Presbyterian Hudson Valley Hospital | Cortlandt Manor | New York |
United States | Broward Health North | Deerfield Beach | Florida |
United States | Ruan Neurology Clinic and Research Center | Des Moines | Iowa |
United States | Henry Ford Health System | Detroit | Michigan |
United States | The Duluth Clinic dba Essentia Health Duluth Clinic | Duluth | Minnesota |
United States | Duke Clinic 1L | Durham | North Carolina |
United States | TriWest Research Associates, LLC | El Cajon | California |
United States | Colorado Neurological Institute | Englewood | Colorado |
United States | Medicoricium, LLC | Fairview Heights | Illinois |
United States | SSM Health St. Clare Hospital | Fenton | Missouri |
United States | McLaren Flint | Flint | Michigan |
United States | University of Colorado Denver | Fort Collins | Colorado |
United States | University of California | Fresno | California |
United States | Holzer Clinic LLC | Gallipolis | Ohio |
United States | Glendale Adventist Medical Center | Glendale | California |
United States | Altru Health System | Grand Forks | North Dakota |
United States | St. Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
United States | Spectrum Health Medical Center | Grand Rapids | Michigan |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | Cone Health System | Greensboro | North Carolina |
United States | Greenville Memorial Hospital | Greenville | South Carolina |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Center for Advanced Research Excellence | Hialeah | Florida |
United States | Novant Health Neurology Hickory | Hickory | North Carolina |
United States | The Queen's Medical Center | Honolulu | Hawaii |
United States | Houston Methodist Hospital | Houston | Texas |
United States | Marshall University | Huntington | West Virginia |
United States | Jackson Heart Clinic, P.A. | Jackson | Mississippi |
United States | UHS Wilson Medical Center,Office of Clin Trials | Johnson City | New York |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Sparrow Clinical Research Institute | Lansing | Michigan |
United States | Associates in Neurology, PSC | Lexington | Kentucky |
United States | Collaborative Neuroscience Network, LLC (CNS) | Long Beach | California |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | University of California Los Angeles | Los Angeles | California |
United States | University of Louisville | Louisville | Kentucky |
United States | Bhupesh Dihenia, M.D.,P.A. | Lubbock | Texas |
United States | University of Wisconsin | Madison | Wisconsin |
United States | North Shore University Hospital | Manhasset | New York |
United States | WellStar Medical Group - Neurosurgery | Marietta | Georgia |
United States | Culicchia Neurological Clinic | Marrero | Louisiana |
United States | Methodist University Hospital | Memphis | Tennessee |
United States | Bruce W. Carter, Miami VA Healthcare System | Miami | Florida |
United States | University of Miami | Miami | Florida |
United States | Winthrop University Hospital | Mineola | New York |
United States | Abbott Northwestern Hospital, Radiology Department | Minneapolis | Minnesota |
United States | Centennial Heart Cardiovascular Consultants, LLC | Nashville | Tennessee |
United States | Saint Thomas Health | Nashville | Tennessee |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Tulane University Hospital and Clinic | New Orleans | Louisiana |
United States | Mount Sinai Beth Israel | New York | New York |
United States | Newton-Wellesley Hospital | Newton | Massachusetts |
United States | The Nebraska Medical Center | Omaha | Nebraska |
United States | Bay Neurological Institute | Panama City | Florida |
United States | Huntington Hospital | Pasadena | California |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Bronislava Shafran, MD PC | Phoenix | Arizona |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Oregon Health and Sciences University | Portland | Oregon |
United States | Veterans Affairs Portland Health Care System | Portland | Oregon |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Quincy Physicians and Surgeons Clinic, S.C. | Quincy | Illinois |
United States | Renown Institute for Neurosciences | Reno | Nevada |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Carilion Riverside | Roanoke | Virginia |
United States | Saint Louis University | Saint Louis | Missouri |
United States | St. Louis Heart and Vascular, P.C. | Saint Louis | Missouri |
United States | HealthPartners Neuroscience Center | Saint Paul | Minnesota |
United States | Carol L Pappas, MD PhD PA | Saint Petersburg | Florida |
United States | University of California | San Diego | California |
United States | University of California | San Francisco | California |
United States | Swedish Neuroscience Institute | Seattle | Washington |
United States | Virginia Mason Medical Center | Seattle | Washington |
United States | Sacred Heart Medical Center at RiverBend | Springfield | Oregon |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | University of South Florida | Tampa | Florida |
United States | Vero Beach Neurology and Research Institute | Vero Beach | Florida |
United States | Palm Beach Neuroscience Institute | West Palm Beach | Florida |
United States | Abington Neurological Associates | Willow Grove | Pennsylvania |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | Advanced Neurology Associates | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adjudicated Recurrent Stroke | Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. | From randomisation until full follow up period, approximately 43 months. | |
Primary | First Major Bleed (Adjudicated) | First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows: Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or, Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of =2 units of blood or packed cells (equivalent to =4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or, Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period. |
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | |
Secondary | Adjudicated Ischaemic Stroke | Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. | From randomisation until full follow up period, up to 43 months | |
Secondary | Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death | Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period. | From randomisation until full follow up period, up to 43 months | |
Secondary | Disabling Stroke | Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period. | From randomisation until full follow up period, up to 43 months | |
Secondary | All-cause Death | All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period. | From randomisation until full follow up period, up to 43 months | |
Secondary | Adjudicated Intracranial Hemorrhage | Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic. The annualised event rate represents the average number of events per patient during a 1-year period. |
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | |
Secondary | Adjudicated Fatal Bleed | Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated. | Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | |
Secondary | Adjudicated Life-threatening Bleed | Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention. The annualised event rate represents the average number of events per patient during a 1-year period. |
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. | |
Secondary | Any Bleed (Investigator-reported) | This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity. The annualised event rate represents the average number of events per patient during a 1-year period. |
Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months. |
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