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

Xijing Hospital400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Ischemic Stroke

Interventions

low-dose aspirinDRUG

50mg aspirin is used to prevent recurrent stroke.

conventional-does aspirinDRUG

100mg aspirin is used to prevent recurrent stroke.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with cerebral infarction diagnosed clinically as non-cardioembolic ischemic stroke; 2. Age ≥ 18 years; 3. Onset time ≤ 3 weeks; 4. At least one cerebral microbleeds lesion was found on SWI; 5. Informed consent was signed. Exclusion Criteria: 1. Patients with symptomatic intracranial hemorrhage; 2. No microbleeds or bleeding lesion \> 10 mm was found on SWI; 3. Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present; 4. Clear anticoagulant indications (such as atrial fibrillation); 5. There are contraindications for aspirin use; 6. The focus of microbleeds is limited to the cortex or other evidence suggests that the patient has cerebral amyloid angiopathy; 7. Patients with coronary heart disease or other diseases need to take antiplatelet drugs; 8. Serious systemic diseases; 9. Refusal to sign informed consent or poor compliance.

Locations (6)

Baoji Central Hospital

Baoji, Shaanxi, China

RECRUITING

Department of Neurology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

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.

Time frame: 6 months after onset

Secondary Outcomes

Stroke recurrence rate

recurrence rate of ischemic stroke

Time frame: 6 months after onset

The incidence of cerebral hemorrhage

Time frame: 6 months after onset

Central Contacts

Wen Jiang, Ph.D

CONTACT

86-029-84771319 jiangwen@fmmu.edu.cn

Fang Yang, Ph.D

CONTACT

86-029-84771319 fyangx@fmmu.edu.cn

Data from ClinicalTrials.gov

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