ACTIVE_NOT_RECRUITING

Efficacy of Clopidogrel on Incidence of Silent Brain Infarction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-03-30

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04698031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Calin Ioan Prodan, MD

PRINCIPAL_INVESTIGATOR

Oklahoma City VA Medical Center, Oklahoma City, OK

Study Locations (Sites)

Oklahoma City VA Medical Center, Oklahoma City, OK

Oklahoma City, Oklahoma, 73104-5007

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Calin Ioan Prodan, MD, PRINCIPAL_INVESTIGATOR, Oklahoma City VA Medical Center, Oklahoma City, OK

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2022-03-30

Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

Silent Brain Infarction