CES1 Carriers in the PAPI Study
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|ClinicalTrials.gov Identifier: NCT03188705|
Recruitment Status : Enrolling by invitation
First Posted : June 15, 2017
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Coronary Disease Coronary Artery Disease Cardiovascular Diseases Myocardial Ischemia Artery Occlusion Aspirin Sensitivity Clopidogrel, Poor Metabolism of Platelet Dysfunction Platelet Thrombus||Drug: Clopidogrel Drug: Aspirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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|
|Official Title:||Enrichment of CES1 Carriers in the Pharmacogenomics Anti-Platelet Intervention Study|
|Actual Study Start Date :||October 14, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Overall Cohort
Participants will receive clopidogrel treatment alone (300 mg loading dose followed by 75 mg/d for 6 days), followed by clopidogrel (75 mg) plus aspirin (324 mg) treatment on day 8.
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.
Other Name: Plavix
Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
- Changes in Platelet Function in Response to Clopidogrel [ Time Frame: Measured at baseline and after 8 days of clopidogrel treatment ]Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation
- Changes in Platelet Function in Response to Clopidogrel Plus Aspirin [ Time Frame: Measured at baseline and after 8 days clopidogrel administration plus 1 day of aspirin treatment ]Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188705
|United States, Pennsylvania|
|Amish Research Clinic|
|Lancaster, Pennsylvania, United States, 17602|
|Principal Investigator:||Joshua P Lewis, PhD||University of Maryland, College Park|