drugset / Trial / NCT00986050
Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction
Phase 4
Completed
907 enrolled
Catharina Ziekenhuis Eindhoven
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabCATHREINE ( data monitoring) · collabCompusense Oegstgeest ( electronic randomization and CRF) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.
Timeline
- Start
- 2006-01
- Primary completion
- 2008-05
- Completion
- 2009-07
Publications
- Background Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
- Background Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansieri M, Choussat R, Pinton P; ADMIRAL Investigators. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001 Jun 21;344(25):1895-903. doi: 10.1056/NEJM200106213442503.
- Background Schomig A, Schmitt C, Dibra A, Mehilli J, Volmer C, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Berger PB, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel. Eur Heart J. 2005 Jul;26(14):1379-84. doi: 10.1093/eurheartj/ehi174. Epub 2005 Feb 25.
- Wijnbergen I, Helmes H, Tijssen J, Brueren G, Peels K, van Dantzig JM, Van' t Veer M, Koolen JJ, Pijls NH, Michels R. Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study. JACC Cardiovasc Interv. 2012 Mar;5(3):313-22. doi: 10.1016/j.jcin.2011.11.009.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abciximab | Monoclonal antibody | 0.125 ug/kg | — |