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

Sponsor

Xijing Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04504864

Collaborator

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

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

66.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: low-dose aspirin Drug: conventional-does aspirin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Stroke recurrence rate [6 months after onset]
recurrence rate of ischemic stroke
The incidence of cerebral hemorrhage [6 months after onset]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baoji Central Hospital	Baoji	Shaanxi	China
2	Department of Neurology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi	China	710032
3	Tangdu Hospital	Xi'an	Shaanxi	China	710038
4	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shaanxi	China
5	Xi'an Central Hospital	Xi'an	Shaanxi	China
6	Xianyang Central Hospital	Xianyang	Shaanxi	China	712000