drugset / Trial / NCT00370045
Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare levels of clot formation (platelet aggregation), markers of heart muscle damage, and inflammation in two groups undergoing percutaneous coronary stent implantation. The first group will be on a regimen of high-dose clopidogrel used in combination with bivalirudin plus eptifibatide, and the second group will be on a regimen of high-dose clopidogrel with bivalirudin alone. Clinical outcomes will be determined up to one year after enrollment.
Timeline
- Start
- 2006-03
- Primary completion
- —
- Completion
- —
Publications
- Lewis JP, Ryan K, O'Connell JR, Horenstein RB, Damcott CM, Gibson Q, Pollin TI, Mitchell BD, Beitelshees AL, Pakzy R, Tanner K, Parsa A, Tantry US, Bliden KP, Post WS, Faraday N, Herzog W, Gong Y, Pepine CJ, Johnson JA, Gurbel PA, Shuldiner AR. Genetic variation in PEAR1 is associated with platelet aggregation and cardiovascular outcomes. Circ Cardiovasc Genet. 2013 Apr;6(2):184-92. doi: 10.1161/CIRCGENETICS.111.964627. Epub 2013 Feb 7.
- Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W, Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA. 2009 Aug 26;302(8):849-57. doi: 10.1001/jama.2009.1232.
- Gurbel PA, Bliden KP, Saucedo JF, Suarez TA, DiChiara J, Antonino MJ, Mahla E, Singla A, Herzog WR, Bassi AK, Hennebry TA, Gesheff TB, Tantry US. Bivalirudin and clopidogrel with and without eptifibatide for elective stenting: effects on platelet function, thrombelastographic indexes, and their relation to periprocedural infarction results of the CLEAR PLATELETS-2 (Clopidogrel with Eptifibatide to Arrest the Reactivity of Platelets) study. J Am Coll Cardiol. 2009 Feb 24;53(8):648-57. doi: 10.1016/j.jacc.2008.10.045.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalirudin | Peptide | — | — |
| Subject | Eptifibatide | Other / unclassified | — | — |