drugset / Trial / NCT00822666
Clopidogrel and Response Variability Investigation Study 2
Phase 3
Completed
109 enrolled
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France · collab
RandomizedCrossoverOpen-labelTreatment
Summary
To evaluate the role of the genetic variant 2C19\*2 on the pharmacodynamic response as assessed by optical aggregometry and on the pharmacokinetic response as assessed by measuring active metabolites following an oral administration of a loading dose of 300/900mg of clopidogrel in patients with established coronary artery disease.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Hulot JS, Collet JP, Cayla G, Silvain J, Allanic F, Bellemain-Appaix A, Scott SA, Montalescot G. CYP2C19 but not PON1 genetic variants influence clopidogrel pharmacokinetics, pharmacodynamics, and clinical efficacy in post-myocardial infarction patients. Circ Cardiovasc Interv. 2011 Oct 1;4(5):422-8. doi: 10.1161/CIRCINTERVENTIONS.111.963025. Epub 2011 Oct 4.
- Collet JP, Hulot JS, Anzaha G, Pena A, Chastre T, Caron C, Silvain J, Cayla G, Bellemain-Appaix A, Vignalou JB, Galier S, Barthelemy O, Beygui F, Gallois V, Montalescot G; CLOVIS-2 Investigators. High doses of clopidogrel to overcome genetic resistance: the randomized crossover CLOVIS-2 (Clopidogrel and Response Variability Investigation Study 2). JACC Cardiovasc Interv. 2011 Apr;4(4):392-402. doi: 10.1016/j.jcin.2011.03.002.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clopidogrel | Small molecule | 300 mg | Oral |
| Subject | Clopidogrel | Small molecule | 900 mg | Oral |