Effect of Clopidogrel on Silent Brain Infarctions
Stroke and Coated-Platelets - A Translational Research Initiative
This study is testing if the medication clopidogrel can help prevent silent brain infarctions in people who have had an ischemic stroke or a transient ischemic attack.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT04698031 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of clopidogrel in reducing the incidence of silent brain infarctions (SBIs) in patients who have experienced an ischemic stroke or transient ischemic attack (TIA). SBIs are often undetected but can lead to significant cognitive decline and increased risk of future strokes. Participants will be monitored over a 24-month period to assess changes in coated-platelet levels and the occurrence of new SBIs. The study aims to provide insights into the potential of clopidogrel as a preventive treatment for these covert cerebrovascular events.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with ischemic stroke or TIA within the last 90 days who are not currently on antiplatelet therapy.
Not a fit: Patients with dementia, those who have had symptoms for more than 90 days, or individuals who cannot tolerate the study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for silent brain infarctions, potentially reducing the risk of subsequent strokes and cognitive decline in at-risk patients.
How similar studies have performed: While studies on silent brain infarctions are limited, the approach of using clopidogrel to target coated-platelet levels shows promise based on preliminary findings in related research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oklahoma City, Oklahoma
- Oklahoma City VA Medical Center, Oklahoma City, OK — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Calin Ioan Prodan, MD — Oklahoma City VA Medical Center, Oklahoma City, OK
- Study coordinator: Calin I Prodan, MD
- Email: calin.prodan@va.gov
- Phone: (405) 456-1479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.