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

February 7, 2022 updated by: Xijing Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Baoji, Shaanxi, China
        • Recruiting
        • Baoji Central Hospital
        • Contact:
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tangdu Hospital
        • Principal Investigator:
          • Wei Zhang, MD
        • Contact:
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Neurology, Xijing Hospital, Fourth Military Medical University
        • Contact:
      • Xi'an, Shaanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Medical University
        • Contact:
      • Xi'an, Shaanxi, China
      • Xianyang, Shaanxi, China, 712000
        • Recruiting
        • Xianyang Central Hospital
        • Contact:
          • Tao Han, MD
          • Phone Number: +8615399259050
        • Principal Investigator:
          • Changhu Xue, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Xi'an Central Hospital
Shaanxi Provincial People's Hospital
Tang-Du Hospital
Baoji Central Hospital
Xiangyang Central Hospital
The First Affiliated Hospital of Jiaotong University
The First Affiliated Hospital of Xi'an Medical University

Investigators

  • Study Director: Wen Jiang, Ph.D, Department of Neurology, Xijing Hospital, Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20202059-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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