Antiplatelet Therapy for Silent Brain Infarction

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry point for secondary prevention, convincing evidence with regard to the preventive efficacy of antiplatelet therapy against incident stroke in SBI is scant. Investigators examine if antiplatelet therapy can effectively decrease the incidence of future stroke in SBI individuals.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First People's Hospital of Shenyang
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• cerebral infarction(s) identified by CT/MRI (≥ 3mm in diameter)

• absence of signs or symptoms of neurological dysfunction ascribed to the lesion(s)

• absence of PMH of neurological dysfunctions due to CNS lesion(s)

Exclusion Criteria:

• Age under 45 years or above 80 years

• PMH of ICH within 180 days

• PMH of lobar hemorrhage of anytime

• Neuroimaging evidence suggesting cerebral microbleeds

• High risk of bleeding (e.g. recurrent gastrointestinal or genitourinary bleeding, active peptic ulcer disease)

• Anticipated requirement for long-term use (more than 28 days) of anticoagulants (e.g. recurrent deep vein thrombosis)

• Prior long-term use of anticoagulants (more than 28 days) or antiplatelet agents (more than 28 days)

• Prior retinal stroke/TIA (diagnosed either clinically or by imaging)

• Intolerance or contraindications to aspirin (including thrombocytopenia, prolonged INR)

• Prior ipsilateral carotid endarterectomy/stent

• Stenosis of culprit artery ≥ 70% (detected by ultrasound, MRA, CTA or DSA)

• Atrial fibrillation, or acute myocardial infarction, or acute congestive heart failure

• Impaired renal function: glomerular filtration rate<60

• Mini Mental Status Examination score<24 (adjusted for age and education)

• Medical contraindication to MRI

• Pregnancy or women of child-bearing potential who are not following an effective method of contraception

• Unable or unwilling to provide informed consent

• Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits

• Patients concurrently participating in another study with an investigational drug or device

• Independence ascribed to limb deformity or prior disability

• Acute myocardial infarction

• Acute congestive heart failure

• Other anticipated reasons for future application of antiplatelet agents other than aspirin (eg. recent stenting, interventional surgeries, Lower-Extremity Atherosclerotic Arterial Disease etc)