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Efficacy of Clopidogrel on Incidence of Silent Brain Infarction

NCT04698031 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

  • Silent Brain Infarction

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Calin Ioan Prodan, MD · Oklahoma City VA Medical Center, Oklahoma City, OK

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2026-05-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698031 on ClinicalTrials.gov