Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239120
• Other study ID #: 1160.189
• Secondary ID: 2013-003444-24
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2014
• Est. completion date: August 14, 2018

Study information

• Verified date: August 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Secondary Prevention
• Stroke

Intervention

Drug:
• optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
• placebo to ASA
placebo to comparator drug
• placebo to optional ASA as comedication
optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
• placebo to dabigatran etexilate
placebo
• ASA 100 mg
active comparator drug
• dabigatran etexilate
active drug

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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, 

Outcome

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.

External Links

•   Link