Clinical trial NCT04504864: Low-dose Aspirin Therapy in Patients With Ischemic Stroke and Microbleeds
Official title: Low-dose Aspirin Therapy in Patients With Non-Cardioembolic Ischemic Stroke and Microbleeds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
microbleeds
Clinical trial
Aspirin
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Shaanxi Provincial People's Hospital
name: The First Affiliated Hospital of Jiaotong University
name: Tang-Du Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Xi'an Central Hospital
name: Xiangyang Central Hospital
name: Baoji Central Hospital
First posted: 2020-08-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increase of cerebral microbleeds
timeFrame: 6 months after onset
Secondary outcomes:
measure: Stroke recurrence rate
timeFrame: 6 months after onset
measure: The incidence of cerebral hemorrhage
timeFrame: 6 months after onset
Other outcomes:
Locations:
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Department of Neurology, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang Central Hospital
state: Shaanxi
Study officials:
affiliation: Department of Neurology, Xijing Hospital, Fourth Military Medical University
name: Wen Jiang, Ph.D
role: STUDY_DIRECTOR
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