Low-dose Aspirin Therapy in Patients With Non-Cardioembolic Ischemic Stroke and Microbleeds
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Increase of cerebral microbleeds
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of low-dose (50mg) aspirin as a secondary prevention drug in patients with Non-Cardioembolic Ischemic Stroke accompanied by cerebral microbleeds.
详细描述
Cerebral microbleeds are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Aspirin is the most widely used anti-thrombotic drug in the secondary prevention of patients with non-cardioembolic ischemic stroke. Studies have shown that conventional doses of aspirin can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe anti-thrombotic therapy is still unclear.
The AIM study aims to provide reliable data on the effects of low-dose Aspirin (50mg target recruitment 200) in patients with non-cardioembolic ischemic stroke and cerebral microbleeds compared to conventional dose (100mg target recruitment 200). Patients presenting with acute (<3 weeks) non-cardioembolic ischemic stroke and microbleeds (≧1 microbleeds in SWI scans) will be randomly assigned to the secondary stroke prevention therapy of low-dose or conventional dose aspirin for 6 months.
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
- Double (Investigator, 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
- •Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke;
- •Age ≥ 18 years;
- •Onset time ≤ 3 weeks;
- •At least one cerebral microbleeds lesion was found on SWI;
- •Informed consent was signed.
排除标准
- •Patients with symptomatic intracranial hemorrhage;
- •No microbleeds or bleeding lesion > 10 mm was found on SWI;
- •Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
- •Clear anticoagulant indications (such as atrial fibrillation);
- •There are contraindications for aspirin use;
- •The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy;
- •Patients with coronary heart disease or other diseases need to take antiplatelet drugs;
- •Serious systemic diseases;
- •Refusal to sign informed consent or poor compliance.
研究组 & 干预措施
low-dose aspirin
Management policy is to use 50 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 50mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke. But this dose is rarely used clinically, especially in East Asia area.
干预措施: low-dose aspirin (Drug)
conventional-does aspirin
Management policy is to use 100 mg aspirin per day as a secondary prevention strategy for patients with non-cardioembolic ischemic stroke and microbleeds. 100mg aspirin is recommended by the guideline of ASA/AHA in prevention of stroke, and this dose is widely used clinically.
干预措施: conventional-does aspirin (Drug)
结局指标
主要结局
Increase of cerebral microbleeds
时间窗: 6 months after onset
How many cerebral microbleeds increased after 6 months of aspirin treatment. Cerebral microbleeds will be detected by MR-SWI in the acute stage and 6 months after the onset of stroke.
次要结局
- Stroke recurrence rate(6 months after onset)
- The incidence of cerebral hemorrhage(6 months after onset)