CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 6 enrolled
Drug / intervention
Clopidogrel +1 moredrug
Likely dose
Clopidogrel 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03188705
NCT03188705Phase 4Completed
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Enrichment of CES1 Carriers in the Pharmacogenomics Anti-Platelet Intervention Study

University of Maryland, Baltimore·interventional·Posted Jun 15, 2017·Updated Jun 15, 2023

In Brief

A Phase 4 clinical trial evaluating Clopidogrel and Aspirin for Heart Diseases and 9 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This study builds, in part, upon preliminary results generated as part of the Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1) on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and aspirin), as assessed by ex vivo platelet aggregometry, in healthy Amish individuals. The investigators hypothesize that participants who carry alleles that modify the activity or expression of CES1 will have altered response to clopidogrel as well as dual antiplatelet therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Diseases, Coronary Disease, Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Artery Occlusion, Aspirin Sensitivity, Clopidogrel, Poor Metabolism of, Platelet Dysfunction, Platelet Thrombus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 15, 2017
Enrollment StartOct 14, 2019
Primary CompletionJan 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.0 years ago

Interventions

Clopidogreldrug

Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration.

Aspirindrug

Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.