CES1 Crossover Trial of Clopidogrel and Ticagrelor

Completed · Phase 4

Conditions studied: Myocardial Infarction, Thrombosis, Platelet Dysfunction

In brief

The purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor. We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel platelet aggregation while having a minimal effect in ticagrelor-treated subjects. Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function.

Key facts

Study ID

NCT03161678

Run by

University of Maryland, Baltimore

People needed

111

Starts

2017-08-22

Expected to finish

2022-12-12

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Of Amish descent
• Age 18 to 75 years
• Participant in the Phamacogenomics of Anti-Platelet Intervention (PAPI-1) Study or other Amish Research Center study, or a family member of an Amish Research Center study participant.

You may not qualify if…

• Clopidogrel or ticagrelor allergy
• Platelet count < 100,000 mm3 or > 500,000 mm3
• Hematocrit (Hct) < 32% or > 50%
• Blood pressure > 160/95 mm Hg
• Co-existing malignancy
• Creatinine > 2.0 mg/dl
• Aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal
• Thyroid-stimulating hormone (TSH) < 0.40 or > 5.50 mU/L
• Pregnant or breast feeding
• History of gastrointestinal bleeding, a major life-threatening bleeding event, active pathological bleeding, bleeding diathesis, or coagulopathy
• History of stroke or transient ischemic attack, deep vein thrombosis, or atrial fibrillation
• History of myocardial infarction, coronary artery bypass surgery, unstable angina, or angioplasty
• History of sick sinus syndrome, 2nd or 3rd degree atrioventricular block, or bradycardia-related syncope
• Type 1 or Type 2 diabetes mellitus
• Surgery in the past 3 months or planned surgery in the next 3 months
• Participant cannot willingly and safely discontinue medications that, in the opinion of the study physician would affect the outcomes to be measured for at least 1 week prior to study initiation through completion of the study
• Participant is unwilling to discontinue taking vitamins and/or supplements that, in the opinion of the study physician would affect the outcomes to be measured for 1 week prior to the study initiation through the the completion of the study
• Any other condition that would place prospective participants at unacceptable risk or render them unable to meet the requirements of the protocol in the opinion of the site investigator

Where it is running

• Amish Research Clinic — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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