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NCT03161678

CES1 Crossover Trial of Clopidogrel and Ticagrelor

Completed Phase 4 Results posted Last updated 6 May 2024
What this trial tests

Phase 4 trial testing Clopidogrel in Myocardial Infarction in 111 participants. Completed in 12 December 2022.

Timeline
22 August 2017
Primary endpoint
12 December 2022
12 December 2022

Quick facts

Lead sponsorUniversity of Maryland, Baltimore
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment111
Start date22 August 2017
Primary completion12 December 2022
Estimated completion12 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 75, any sex, with Myocardial Infarction or Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Randomized evaluation of the loss-of-function carboxylesterase 1 (CES1) G143E variant on clopidogrel and ticagrelor pharmacodynamics.
    Lewis JP, Ryan KA, Streeten EA, Whitlatch HB, et al · · 2024 · cited 3× · PMID 39576732 · DOI 10.1111/cts.70079

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Other trials of Clopidogrel

Trials testing the same drug.

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other University of Maryland, Baltimore trials

Trials by the same sponsor.

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Data sources for this page

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