CES1 Carriers in the PAPI Study

Completed · Phase 4

Conditions studied: Heart Diseases, Coronary Disease, Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Artery Occlusion, Aspirin Sensitivity, Clopidogrel, Poor Metabolism of, Platelet Dysfunction, Platelet Thrombus

In brief

This study builds, in part, upon preliminary results generated as part of the Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1) on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and aspirin), as assessed by ex vivo platelet aggregometry, in healthy Amish individuals. The investigators hypothesize that participants who carry alleles that modify the activity or expression of CES1 will have altered response to clopidogrel as well as dual antiplatelet therapy.

Key facts

Study ID: NCT03188705
Run by: University of Maryland, Baltimore
People needed: 6
Starts: 2019-10-14
Expected to finish: 2020-01-17
Last updated by the study team: 2026-07-31

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age 20 years or older
Of Old Order Amish descent

You may not qualify if…

Currently pregnant or less than 6 months have passed since delivery
Currently breast feeding
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
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 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 anti-coagulants, such as warfarin, heparin, or GPIIb/IIIa antagonists, and have conditions that might place the participant at increased risk from withdrawal of these medications 14 days prior to protocol initiation
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

Where it is running

Amish Research Clinic — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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