CES1 Carriers in the PAPI Study

Last updated on July 2021

Recruitment

Recruitment Status: Enrolling by invitation
Estimated Enrollment: Same as current

Summary

Conditions

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

Type

Interventional

Phase

Phase 4

Design

Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The investigators will enroll 50 healthy Amish participants who have been identified through existing whole genome and exome sequencing along with bioinformatic approaches that have genetic variants that are predicted to significantly impact CES1 expression or catalytic function. Enrolled participants will undergo a two-stage intervention with clopidogrel (300 mg loading dose then 75 mg per day for the next 6 days), followed by clopidogrel (75 mg) plus aspirin 324 mg for 1 day. Platelet aggregation studies and other measures of platelet function will be performed before and after each intervention. In combination with previously collected data as part of the PAPI Study, the investigators will then characterize the impact of genetic variation in CES1 on clopidogrel and dual antiplatelet therapy response through single- and multi-variant association modeling.Masking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age: Between 20 years and 125 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #: NCT03188705
Collaborators: Not Provided
Investigators: Principal Investigator: Joshua P Lewis, PhD University of Maryland, College Park