NCT03188705

CES1 Carriers in the PAPI Study

Enrichment of CES1 Carriers in the Pharmacogenomics Anti-Platelet Intervention Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Diseases
• Coronary Disease
• Coronary Artery Disease
• Cardiovascular Diseases
• Myocardial Ischemia
• Artery Occlusion
• Aspirin Sensitivity
• Clopidogrel, Poor Metabolism of
• Platelet Dysfunction
• Platelet Thrombus

Interventions

Type	Name	Description
DRUG	Clopidogrel	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.
DRUG	Aspirin	Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-01-17
• Completion: 2020-01-17
• First posted: 2017-06-15
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study