Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
One of the most common ways for preventing coronary heart disease (CHD) is to take aspirin or clopidogrel. However, studies have shown that not all people respond to these medications. The variance in treatment response may be linked to genetics. This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses.
Platelet Aggregation Inhibitors
Coronary Heart Disease
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study)|
- Changes in platelet function in response to clopidogrel and clopidogrel plus aspirin [ Time Frame: Measured at baseline, before and after clopidogrel treatment, and after clopidogrel plus aspirin treatment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
300 mg on first day, then 75 mg per day for the next 6 daysDrug: Aspirin
Single dose of 324 mg on the last day of clopidogrel treatment
CHD is the leading cause of death in the United States. Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events. Two of the most common anti-platelet agents are aspirin and clopidogrel. However, up to 25% to 30% of people do not respond to these medications. Evidence indicates that treatment response may be related to genetics. The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy.
This study is part of a larger group of studies called the Pharmacogenomics Research Network (PGRN). Participants will include the Old Order Amish of Lancaster, Pennsylvania. They are well suited for genetic studies because they are a homogenous, closed, founder population. Participants will receive 300 mg of clopidogrel on the first day, then 75 mg of clopidogrel per day for the next 6 days. On the last day of clopidogrel treatment, participants will take a single dose of 324 mg aspirin. Participants will undergo platelet function tests before and after clopidogrel alone, and then again after taking clopidogrel plus aspirin. Using the gene variation profiles across the genome, researchers will analyze which genes correspond to treatment response.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799396
|Contact: Alan R. Shuldiner, MDemail@example.com|
|United States, Pennsylvania|
|Amish Research Clinic||Recruiting|
|Lancaster, Pennsylvania, United States, 17601|
|Contact: Mary Morrissey 717-392-4948 firstname.lastname@example.org|
|Principal Investigator:||Alan R. Shuldiner, MD||University of Maryland|