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

Phase 4

• Conditions: Ischemic Stroke
• Interventions: Drug: conventional-does aspirin; Drug: low-dose aspirin

• Registration Number: NCT04504864
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Study Start: 2020-10-01
• Status Verified: 2022-01
• Primary Completion: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional-does aspirin	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.
low-dose aspirin	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.

Primary Outcome Measures

Name	Time	Method
Increase of cerebral microbleeds	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.

Secondary Outcome Measures

Name	Time	Method
Stroke recurrence rate	6 months after onset	recurrence rate of ischemic stroke
The incidence of cerebral hemorrhage	6 months after onset

Trial Locations

Locations (6)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China

Baoji Central Hospital; 🇨🇳 Baoji, Shaanxi, China

Department of Neurology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China

Xianyang Central Hospital; 🇨🇳 Xianyang, Shaanxi, China

The First Affiliated Hospital of Xi'an Medical University; 🇨🇳 Xi'an, Shaanxi, China

Xi'an Central Hospital; 🇨🇳 Xi'an, Shaanxi, China