Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
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| ClinicalTrials.gov Identifier: NCT00799396 |
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Recruitment Status :
Completed
First Posted : November 27, 2008
Results First Posted : March 28, 2016
Last Update Posted : February 24, 2022
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| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Pharmacogenomics of Anti-Platelet Interventions (The PAPI Study) |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | February 2012 |
| Actual Study Completion Date : | February 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Overall Study
Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.
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Drug: Clopidogrel
300 mg on first day, then 75 mg per day for the next 6 days Drug: 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
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Of Old Order Amish descent
Exclusion Criteria:
- Currently pregnant or less than 6 months have passed since delivery
- Has a history of a bleeding disorder or major spontaneous bleed, such as peptic ulcer, epistasis, or intracranial bleed
- Has severe hypertension, defined by a blood pressure above 160/95 mm Hg, making it unethical not to recommend prompt treatment
- Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation
- Is taking vitamins or other supplements and is unwilling to discontinue their use for at least 1 week prior to study
- Has a coexisting malignancy
- Has a creatinine level greater than 2.0 mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) greater than two times the upper limit of normal, hematocrit less than 32%, or a thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 mIU/L
- Has a bleeding disorder or history of gastrointestinal bleeding or other major bleeding episode
- Is currently taking aspirin, clopidogrel, or other anti-coagulant, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place them at increased risk from withdrawal of these medications 14 days prior to protocol initiation, including history of unstable angina, heart attack, angioplasty (including stent placement), coronary artery bypass surgery, atrial fibrillation, stroke or transient ischemic attacks, diabetes, or deep vein thrombosis or other thrombosis
- Has polycythemia, or thrombocytosis, defined by a platelet count greater than 500,000
- Has thrombocytopenia, defined by a platelet count less than 75,000
- Has had surgery within the last 6 months
- Has an aspirin or clopidogrel allergy
- Currently breast feeding
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 School of Medicine |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alan Shuldiner, Associate Dean for Personalized Medicine; Director, Program in Personalized and Genomic Medicine; Head, Division of Endocrinology, Diabetes and Nutrition, University of Maryland, Baltimore |
| ClinicalTrials.gov Identifier: | NCT00799396 |
| Other Study ID Numbers: |
HP-00043419 U01 HL074518-01 U01GM074518 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 27, 2008 Key Record Dates |
| Results First Posted: | March 28, 2016 |
| Last Update Posted: | February 24, 2022 |
| Last Verified: | February 2022 |
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Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Aspirin Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |