Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 7,213
- 主要终点
- Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)
研究概览
简要总结
This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent ESUS (between 7 days and 6 months), defined as:
- •Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
- •Absence of cervical carotid atherosclerotic stenosis> 50% or occlusion, and
- •No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
- •No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
- •No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
排除标准
- •Severely disabling stroke (modified Rankin score ≥4)
- •Indication for chronic anticoagulation or antiplatelet therapy
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
研究组 & 干预措施
Rivaroxaban
Rivaroxaban 15 mg orally once daily
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Rivaroxaban
Rivaroxaban 15 mg orally once daily
干预措施: Rivaroxaban-Placebo (Other)
Aspirin
Aspirin 100 mg orally once daily
干预措施: Acetylsalicylic acid (Aspirin, BAY1019036) (Drug)
Aspirin
Aspirin 100 mg orally once daily
干预措施: Aspirin-Placebo (Other)
结局指标
主要结局
Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)
时间窗: From randomization until the efficacy cut-off date (median 326 days)
Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (\>=) 2 grams per decilitre (g/dL) (20 grams per liter \[g/L\]; 1.24 millimoles per liter \[mmol/L\]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.
Incidence Rate of the Composite Efficacy Outcome (Adjudicated)
时间窗: From randomization until the efficacy cut-off date (median 326 days)
Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
次要结局
- Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction(From randomization until the efficacy cut-off date (median 326 days))
- Incidence Rate of Intracranial Hemorrhage(From randomization until the efficacy cut-off date (median 326 days))
- Incidence Rate of Life-Threatening Bleeding Events(From randomization until the efficacy cut-off date (median 326 days))
- Incidence Rate of All-Cause Mortality(From randomization until the efficacy cut-off date (median 326 days))
- Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction(From randomization until the efficacy cut-off date (median 326 days))
- Incidence Rate of Clinically Relevant Non-Major Bleeding Events(From randomization until the efficacy cut-off date (median 326 days))