Status:
UNKNOWN
Antiplatelet Therapy for Silent Brain Infarction
Lead Sponsor:
First People's Hospital of Shenyang
Conditions:
Brain Infarction
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief 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 isc...
Detailed Description
SBI is defined as a focal hyperintense lesion on T2-weighted images and/or fluid-attenuated inversion recovery with no corresponding symptoms in the clinical history of the patient that could be attri...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
3400 Patients enrolled
Trial Details
Trial ID
NCT03318744
Start Date
January 1 2018
End Date
December 1 2021
Last Update
October 25 2017
Active Locations (1)
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1
Shenyang Brain Hsopital
Shenyang, Liaoning, China, 110041