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ACTIVE NOT RECRUITING
NCT04698031
PHASE4

Efficacy of Clopidogrel on Incidence of Silent Brain Infarction

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Stroke and Coated-Platelets - A Translational Research Initiative

Key Details

Gender

All

Age Range

21 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2022-03-30

Completion Date

2026-07-01

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

DRUG

Clopidogrel treatment

After randomization, patients will receive clopidogrel 75 mg daily for the duration of the study. The VA Research Pharmacy will dispense similar looking medication with Arm 2 to ensure the double-blind nature of the intervention. Clopidogrel is FDA approved for secondary prevention of stroke. Follow-up will be for 24 months with repeat brain MRI obtained at 24 months to assess for interval presence of silent brain infarctions.

DRUG

Aspirin treatment

After randomization, patients will receive Aspirin 325 mg daily for the duration of the study. The VA Research Pharmacy will dispense similar looking medication with Arm 2 to ensure the double-blind nature of the intervention. Aspirin is FDA approved for secondary prevention of stroke. Follow-up will be for 24 months with repeat brain MRI obtained at 24 months to assess for interval presence of silent brain infarctions.

Locations (1)

Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma, United States