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

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研究单位: [1]Boehringer Ingelheim [2]Tongji Hospital, Tongji University Shanghai, China, 200065 [3]General Hospital of Shenyang Military Region Shenyang, China, 110016 [4]First Affiliated Hospital of Xiamen University Xiamen, China, 361003 [5]Affiliated Hospital, Xuzhou Medical college Xuzhou, China, 221002 [6]Zhejiang Hospital Hangzhou, China, 310013 [7]The Affiliated Hospital of Hangzhou Normal University Hangzhou, China, 310015 [8]Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital Hangzhou, China, 310016 [9]Jinlin Central Hospital Jilin, China, 132602 [10]The Second Affiliated Hospital to Nanchang University Nanchang, China, 330006 [11]Nanjing Drum Tower Hospital Nanjing, China, 210008 [12]Zhongda Hospital Southeast University Nanjing, China, 210009 [13]QingDao Municipal Hospital Qingdao, China, 266071 [14]The affiliated hospital of medicalcollege qingdao university Qingdao, China, 266555 [15]Huashan Hospital, Fudan University Shanghai, China, 200040 [16]Servicios Médicos Muñoz Solano Bogotá, Colombia [17]Sociedad de Cirugia de Bogota Hospital de San José Bogotá, Colombia [18]Fundación Cardiovascular de Colombia Floridablanca, Colombia [19]General Hospital Varazdin Varazdin, Croatia, 42000 [20]Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care Zagreb, Croatia, 10 000

研究目的:
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).

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