Active — Not RecruitingPhase 4

Efficacy of Clopidogrel on Incidence of Silent Brain Infarction

United States134 participantsStarted 2022-03-30

Plain-language summary

Silent brain infarctions (SBIs) are a manifestation of covert cerebrovascular disease, without obvious clinical deficit, noted very often in patients presenting with a new stroke or new transient ischemic attack. SBIs are linked to a significant increase in risk for subsequent stroke and cognitive decline. However, no biomarker is currently available that can predict the recurrence of these subclinical lesions. Coated-platelets are a measure of platelet procoagulant potential significantly increased in patients with ischemic stroke or transient ischemic attack compared to unaffected controls. Higher coated-platelet levels are strongly associated with both the presence and number of SBIs. Among medications approved for preventing stroke recurrence, we identified clopidogrel as a pharmacological agent leading to a decrease in coated-platelet levels. In this project, we plan to evaluate if clopidogrel can decrease the rate of occurrence of new silent brain infarctions. The result will enhance the investigators understanding of the relationship between platelets and silent brain infarcts, leading to improved health care delivery and also potential targets for novel preventive pharmacological interventions.

Who can participate

Age range21 Years – 90 Years

SexALL

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Inclusion Criteria: * diagnosis of ischemic stroke/TIA * \< 90 days from onset of symptoms * initial MRI available, * not receiving antiplatelet therapy at the time of admission * medical decision by the treating physician that antiplatelet therapy is indicated for secondary prevention (decision independent of the study and based on individual clinical decision for each patient). * baseline coated-platelet levels at 40%, * willingness to participate in the study for 24 months Exclusion Criteria: * dementia (based on chart review or self/proxy report) * \> 90 days from onset of symptoms * initiation of anticoagulation or thrombolytics prior to phlebotomy * intracranial hemorrhage or bleeding diatheses * end-stage renal disease (ESRD) * inability to tolerate consenting or phlebotomy * prior adverse/allergic reactions to clopidogrel * treating physician deemed a different antiplatelet dose or dual antiplatelet therapy as the only treatment choice

What they're measuring

new silent brain infarctions

Timeframe: 24 months

Trial details

NCT IDNCT04698031

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-05-01