The Efficacy and Safety of Cilostazol Compared to Aspirin in Acute Non-Cardioembolic Stroke Patients With Concurrent Cerebral Microbleeds: An Open-Label, Endpoint-Blinded, Randomized Non-Inferiority Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 848
- 试验地点
- 1
- 主要终点
- The rate of recurrent stroke
研究概览
简要总结
The purpose of this clinical trial is to demonstrate that cilostazol is non-inferior to aspirin in terms of efficacy and safety for the secondary prevention of stroke in patients with acute non-cardioembolic ischemic stroke who have concurrent microbleeds. Researchers will compare the medication cilostazol with aspirin to assess its efficacy and safety in these patients.
Participants will:
Take the medication cilostazol or aspirin daily as part of an antiplatelet drug therapy.
Have baseline data and follow-up data collected at the time of hospital admission, and then at 3 months, 6 months post-discharge, and annually thereafter up to 4 years.
Have the primary endpoint set as stroke recurrence, with secondary endpoints being composite vascular events. Safety events will include moderate to severe hemorrhage and bleeding at any site.
详细描述
The plan is to enroll patients with acute non-cardioembolic stroke who have concurrent cerebral microbleeds (CMBs). After enrollment, patients will be randomly assigned to either the Cilostazol group (experimental group, Cilostazol 100mg, twice daily) or the Aspirin group (control group, Aspirin 100mg, once daily). The treatment goals for blood pressure, blood sugar, and blood lipids will be strictly controlled according to the relevant guidelines. Baseline and follow-up data will be collected at the time of enrollment, and at 3 months, 6 months, and annually (up to 4 years) 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke (within 1 month of onset)
- •Non-cardioembolic stroke
- •Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI)
排除标准
- •Previous diagnosis of cerebral amyloid angiopathy (CAA) according to the Boston 2.0 diagnostic criteria
- •History of intracerebral hemorrhage highly suspected to be caused by CAA-related lobar hemorrhage
- •Severe adverse reactions (such as active bleeding, severe allergies, etc.) to aspirin or cilostazol in the past, leading to non-compliance with medication
- •Requirement for combined anticoagulant therapy
- •Requirement for long-term dual antiplatelet therapy (>1 month)
研究组 & 干预措施
Cilostazol Group
Cilostazol 100mg twice daily
干预措施: Cilostazol (Drug)
Aspirin Group
Aspirin 100mg once daily
干预措施: Aspirin (Drug)
结局指标
主要结局
The rate of recurrent stroke
时间窗: Time Frame: baseline ,3-month,6-month, and every 1 year, follow-up time up to 4 years
Head CT,Brain MRI,Cognitive Evaluation
次要结局
未报告次要终点