Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00799396|
Recruitment Status : Completed
First Posted : November 27, 2008
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Platelet Aggregation Inhibitors Coronary Heart Disease||Drug: Clopidogrel Drug: Aspirin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||682 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study)|
|Study Start Date :||July 2006|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Experimental: Overall Study
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
- Changes in Platelet Function in Response to Clopidogrel [ Time Frame: Measured at baseline, and after 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 clopidogrel plus 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): NCT00799396
|United States, Pennsylvania|
|Amish Research Clinic|
|Lancaster, Pennsylvania, United States, 17601|
|Principal Investigator:||Alan R. Shuldiner, MD||University of Maryland|