drugset / Trial / NCT00774475
Dual Antiplatelet Therapy Tailored on the Extent of Platelet Inhibition
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy (reduction of major ischemic events at 6 and 12 months of follow-up) of a tailored clopidogrel therapy in patients with UA/NSTEMI undergoing PCI with stent implantation and wiht a documented residual platelet reactivity assessed by a point of care system (VerifyNow P2Y12).
Timeline
- Start
- 2008-11
- Primary completion
- 2010-11
- Completion
- 2011-01
Publications
- Background Gori AM, Marcucci R, Migliorini A, Valenti R, Moschi G, Paniccia R, Buonamici P, Gensini GF, Vergara R, Abbate R, Antoniucci D. Incidence and clinical impact of dual nonresponsiveness to aspirin and clopidogrel in patients with drug-eluting stents. J Am Coll Cardiol. 2008 Aug 26;52(9):734-9. doi: 10.1016/j.jacc.2008.05.032.
- Background Buonamici P, Marcucci R, Migliorini A, Gensini GF, Santini A, Paniccia R, Moschi G, Gori AM, Abbate R, Antoniucci D. Impact of platelet reactivity after clopidogrel administration on drug-eluting stent thrombosis. J Am Coll Cardiol. 2007 Jun 19;49(24):2312-7. doi: 10.1016/j.jacc.2007.01.094. Epub 2007 Jun 4.
- Background Price MJ, Endemann S, Gollapudi RR, Valencia R, Stinis CT, Levisay JP, Ernst A, Sawhney NS, Schatz RA, Teirstein PS. Prognostic significance of post-clopidogrel platelet reactivity assessed by a point-of-care assay on thrombotic events after drug-eluting stent implantation. Eur Heart J. 2008 Apr;29(8):992-1000. doi: 10.1093/eurheartj/ehn046. Epub 2008 Feb 10.
- Background Santoro GM, Carrabba N, Barchielli A, Balzi D, Marchionni N, Filice M, Valente S, Granelli M, Berni I, Buiatti E; AMI-Florence Working Group. Use and efficacy of abciximab in an unselected population with acute myocardial infarction treated with primary angioplasty: data from AMI-Florence registry. Atherosclerosis. 2007 Nov;195(1):116-21. doi: 10.1016/j.atherosclerosis.2006.08.053. Epub 2006 Sep 25.
- Background Balzi D, Barchielli A, Buiatti E, Franceschini C, Lavecchia R, Monami M, Santoro GM, Carrabba N, Margheri M, Olivotto I, Gensini GF, Marchionni N; AMI-Florence Working Group. Effect of comorbidity on coronary reperfusion strategy and long-term mortality after acute myocardial infarction. Am Heart J. 2006 May;151(5):1094-1100. doi: 10.1016/j.ahj.2005.06.037.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clopidogrel | Small molecule | 75 mg | — |
| Comparator | Clopidogrel | Small molecule | 150 mg | — |