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COMPLETED
NCT03161678
PHASE4

CES1 Crossover Trial of Clopidogrel and Ticagrelor

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Official title: Impact of Genetic Variation in CES1 on Antiplatelet Therapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2017-08-22

Completion Date

2022-12-12

Last Updated

2026-07-24

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Amish Research Clinic

Lancaster, Pennsylvania, United States