Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low-dose Aspirin Therapy in Patients With Non-Cardioembolic Ischemic Stroke and Microbleeds

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: low-dose aspirin
* Drug: conventional-does aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose aspirin<br>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. | Drug: low-dose aspirin<br>* 50mg aspirin is used to prevent recurrent stroke.<br>|
| Active Comparator: conventional-does aspirin<br>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. | Drug: conventional-does aspirin<br>* 100mg aspirin is used to prevent recurrent stroke.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of cerebral microbleeds | 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. | 6 months after onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke recurrence rate | recurrence rate of ischemic stroke | 6 months after onset | 
| The incidence of cerebral hemorrhage |  | 6 months after onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, microbleeds, Clinical trial, Aspirin