NCT03161678

CES1 Crossover Trial of Clopidogrel and Ticagrelor

Impact of Genetic Variation in CES1 on Antiplatelet Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myocardial Infarction
• Thrombosis
• Platelet Dysfunction

Interventions

Type	Name	Description
DRUG	Clopidogrel	Clopidogrel (75 mg/d for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.
DRUG	Ticagrelor	Ticagrelor (90 mg twice daily for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.

Timeline

• Start date: 2017-08-22
• Primary completion: 2022-12-12
• Completion: 2022-12-12
• First posted: 2017-05-22
• Last updated: 2024-05-06
• Results posted: 2024-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study