CompletedPhase 4

CES1 Crossover Trial of Clopidogrel and Ticagrelor

United States111 participantsStarted 2017-08-22

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 vit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Maximal Platelet Aggregation in Response to Clopidogrel

Timeframe: 8 days of exposure to clopidogrel (change from baseline at day 8 reported)

Change in Maximal Platelet Aggregation in Response to Ticagrelor

Timeframe: 8 days of independent exposure to ticagrelor (change from baseline at day 8 reported)

Trial details

NCT IDNCT03161678

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-12

Results submitted2024-01-17

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