Phase 4
Completed N=682
Determining Genetic Role in Treatment Response to Anti-Platelet Interventions (The PAPI Study)
Platelet Aggregation Inhibitors · Heart Failure
Source: ClinicalTrials.gov NCT00799396 ↗
Enrolled (actual)
682
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Changes in Platelet Function in Response to Clopidogrel — 38.51; 14.06 percentage of maximum aggregation change
◆ Published Evidence
Highly cited
1,506citations · ~89 / year
Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy.
Summary
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.
Linked Publications (5)
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Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy.
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The functional G143E variant of carboxylesterase 1 is associated with increased clopidogrel active metabolite levels and greater clopidogrel response.
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Genetic variation in PEAR1 is associated with platelet aggregation and cardiovascular outcomes.
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Paraoxonase 1 (PON1) gene variants are not associated with clopidogrel response.
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The Pharmacogenomics of Anti-Platelet Intervention (PAPI) Study: Variation in Platelet Response to Clopidogrel and Aspirin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Platelet Function in Response to Clopidogrel |
38.51; 14.06 | — |
| PRIMARY Changes in Platelet Function in Response to Clopidogrel Plus Aspirin |
41.21; 56.64 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00799396) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.