drugset / Trial / NCT03161678

CES1 Crossover Trial of Clopidogrel and Ticagrelor

NCT03161678 ↗

Phase 4 Completed 111 enrolled University of Maryland, Baltimore
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2017-08-22
Primary completion
2022-12-12
Completion
2022-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 75 mg Oral
Subject Ticagrelor Small molecule 90 mg —