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)
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)
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).
Inclusion criteria:
Further inclusion criteria apply.
Exclusion criteria:
Further exclusion criteria apply.
CABA, C1023AAB, Argentina
CABA, C1093AAS, Argentina
CABA, C1199ABD, Argentina
Victoria, Victoria 3004, Australia
Joinvile, 89202-165, Brazil
Tel Hashomer, Ramat Gan, 5265601, Israel
Telaviv, 64239, Israel
Aichi, Nagoya, 455-8530, Japan
Aichi, Toyohashi, 440-8510, Japan
Aichi, Toyota, 471-8513, Japan
Akita, Akita, 010-0874, Japan
Chiba, Urayasu, 279-0021, Japan
Fukuoka, Chikushino, 818-8502, Japan
Fukuoka, Fukuoka, 810-8563, Japan
Fukuoka, Fukuoka, 811-0213, Japan
Fukuoka, Fukuoka, 814-0180, Japan
Fukuoka, Kasuga, 816-0864, Japan
Fukuoka, Kitakyushu, 805-0050, Japan
Fukuoka, Kitakyushu, 806-8501, Japan
Fukuoka, Kurume, 830-8543, Japan
Fukuoka, Kurume, 830-8577, Japan
Fukuoka, Onga, 807-0051, Japan
Fukuoka, Tagawa, 826-8585, Japan
Fukuoka, Yukuhashi, 824-0026, Japan
Fukushima, Nihonmatsu, 964-0867, Japan
Gifu, Gifu, 500-8523, Japan
Gifu, Takayama, 506-8550, Japan
Hiroshima, Hiroshima, 730-0046, Japan
Hiroshima, Hiroshima, 733-0821, Japan
Hiroshima, Hiroshima, 734-8530, Japan
Hyogo, Kobe, 650-0047, Japan
Ibaraki, Toride, 302-0022, Japan
Ibaraki, Tsukuba, 305-8558, Japan
Iwate, Morioka, 020-8505, Japan
Kagoshima, Kagoshima, 890-8760, Japan
Kagoshima, Kagoshima, 892-0853, Japan
Kanagawa, Kamakura, 247-8533, Japan
Kumamoto, Kumamoto, 861-4193, Japan
Kumamoto, Kumamoto, 861-8520, Japan
Kumamoto, Kumamoto, 862-8505, Japan
Kyoto, Uji, 611-0042, Japan
Miyagi, Sendai, 983-8520, Japan
Nagano, Ina, 396-8555, Japan
Nagasaki, Nagasaki, 852-8501, Japan
Osaka, Daito, 574-0074, Japan
Osaka, Higashiosaka, 578-8588, Japan
Osaka, Higashiosaka, 579-8056, Japan
Osaka, Izumisano, 598-8577, Japan
Osaka, Kishiwada, 596-0042, Japan
Osaka, Osaka, 537-0011, Japan
Osaka, Osaka, 556-0017, Japan
Osaka, Suita, 565-0871, Japan
Saitama, Asaka, 351-0023, Japan
Saitama, Hidaka, 350-1298, Japan
Saitama, Saitama, 331-8577, Japan
Saitama, Saitama, 336-8522, Japan
Tokyo, Bunkyo-ku, 113-8603, Japan
Tokyo, Mitaka, 181-8611, Japan
Wakayama, Wakayama, 640-8158, Japan
Yamagata, Yamagata, 990-8533, Japan
Terengganu, 20400, Malaysia
Grafton / Auckland, 1010, New Zealand
Takpuna Auckland, 0622, New Zealand
Santa Maria da Feira, 4520-211, Portugal
Daejoen, 35015, South Korea
Tarrasa (Barcelona), 08221, Spain
Vinnitsia, 21005, Ukraine