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

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    400
  • sponsor
    Xijing Hospital
Updated on 22 March 2022

Summary

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.

Description

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.

Details
Condition Ischemic Stroke
Treatment Low-dose aspirin, conventional-does aspirin
Clinical Study IdentifierNCT04504864
SponsorXijing Hospital
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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