Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,171
- 试验地点
- 2
- 主要终点
- The rate of 90-day Composite events
研究概览
简要总结
The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.
详细描述
Concomitant NVAF and extracranial/intracranial artery stenosis will greatly increase the risk of stroke, even with standard anticoagulation. However, clinicians may be concerned with the high risk of bleeding complications of anticoagulation combined with antiplatelet therapy. The goal of this clinical trial is to evaluate the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Acute ischemic stroke or TIA with onset < 7 days
- •Have a history or newly diagnosed as NVAF
- •Concomitant stenosis (>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory
排除标准
- •Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury
- •Have a history or newly diagnosed as valvular heart disease
- •Mural thrombus in heart
- •Contraindications of anticoagulation or antiplatelet therapy, e.g. severe intracranial hemorrhage
- •Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
- •Have or plan to receive CEA or CAS in the following 3 months
- •Life expectancy less than 1 year
- •Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
- •Pregnant or lactating women
- •Individuals identified by researchers as unsuitable for participation in the study due to other reasons.
研究组 & 干预措施
Anticoagulation alone
Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily
干预措施: Anticoagulant Oral (Drug)
Anticoagulation combined with antiplatelet therapy
Rivaroxaban 20mg once daily or 15mg once daily or 10mg once daily / dabigatran 110mg twice daily or 150mg twice daily+ aspirin 100mg once daily / clopidogrel 75mg once daily / ticagrelor 90mg twice daily / cilostazol 100mg twice daily
干预措施: Anticoagulation combined with antiplatelet therapy (Drug)
结局指标
主要结局
The rate of 90-day Composite events
时间窗: 90 days
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment
次要结局
- The rate of 90-day ischemic stroke(90 days)
- The rate of 90-day hemorrhagic stroke(90 days)
- The rate of 90-day major extracranial hemorrhage(90 days)
- The rate of 90-day myocardial infarction(90 days)
- The rate of 90-day systemic embolism(90 days)
- The rate of 90-day non-major bleeding(90 days)
- The rate of 90-day vascular death(90 days)
- The rate of 90-day all-cause death(90 days)
- Discharge modified Rankin scale score(At discharge, an average of 7 days)