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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,390
- 试验地点
- 562
- 主要终点
- Adjudicated Recurrent Stroke
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ASA 100 mg
All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d
干预措施: placebo to optional ASA as comedication (Drug)
dabigatran etexilate 110 or 150 mg
Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)
干预措施: optional ASA as comedication (Drug)
dabigatran etexilate 110 or 150 mg
Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)
干预措施: placebo to ASA (Drug)
dabigatran etexilate 110 or 150 mg
Patients will be assigned Dabigatran 150 mg b.i.d. (unless they are 75 years or older, or have a Creatinine Clearance (CrCl) of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive Dabigatran 110 mg b.i.d.). All patients in this arm will also receive ASA placebo (q.d.)
干预措施: dabigatran etexilate (Drug)
ASA 100 mg
All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d
干预措施: placebo to dabigatran etexilate (Drug)
ASA 100 mg
All patients will receive blinded ASA 100 mg q.d. and dabigatran placebo 150 mg b.i.d. (unless they are 75 years or older, or have a CrCl of greater than or equal to 30 to less than 50ml/min (or experience GI bleed during trial), in which case they will receive placebo Dabigatran 110 mg b.i.d
干预措施: ASA 100 mg (Drug)
结局指标
主要结局
Adjudicated Recurrent Stroke
时间窗: From randomisation until full follow up period, approximately 43 months.
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.
First Major Bleed (Adjudicated)
时间窗: Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.
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.
次要结局
- All-cause Death(From randomisation until full follow up period, up to 43 months)
- Adjudicated Intracranial Hemorrhage(Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
- Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death(From randomisation until full follow up period, up to 43 months)
- Adjudicated Ischaemic Stroke(From randomisation until full follow up period, up to 43 months)
- Disabling Stroke(From randomisation until full follow up period, up to 43 months)
- Adjudicated Fatal Bleed(Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
- Adjudicated Life-threatening Bleed(Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
- Any Bleed (Investigator-reported)(Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)