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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04504864

Acronym

AIM

Enrollment

400

Registered

2020-08-07

Start date

2020-10-01

Completion date

2022-08-31

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke, microbleeds, Clinical trial, Aspirin

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.

Interventions

DRUGlow-dose aspirin

50mg aspirin is used to prevent recurrent stroke.

DRUGconventional-does aspirin

100mg aspirin is used to prevent recurrent stroke.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Stroke recurrence rate	6 months after onset	recurrence rate of ischemic stroke
The incidence of cerebral hemorrhage	6 months after onset	—

Countries

China

Contacts

Primary ContactWen Jiang, Ph.D

jiangwen@fmmu.edu.cn86-029-84771319

Backup ContactFang Yang, Ph.D

fyangx@fmmu.edu.cn86-029-84771319

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026