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NCT03161678
CES1 Crossover Trial of Clopidogrel and Ticagrelor
Phase 4 trial testing Clopidogrel in Myocardial Infarction in 111 participants. Completed in 12 December 2022.
12 December 2022
Quick facts
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 111 |
| Start date | 22 August 2017 |
| Primary completion | 12 December 2022 |
| Estimated completion | 12 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Clopidogrel (clopidogrel) — full drug profile →
- Ticagrelor (ticagrelor) — full drug profile →
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Thrombosis — all drugs for Thrombosis →
- Platelet Dysfunction — all drugs for Platelet Dysfunction →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03161678
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Maryland, Baltimore trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03161678 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
- Last refreshed: 6 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03161678.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing