Comparison of Drug Eluting & Bare Metal Stents With or Without Abciximab

Status Completed

Clinical Trial 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.

Clinical Trial Description

In patients with acute myocardial infarction primary PCI without prior thrombolytic therapy, is the treatment of choice.

The recommendation for routine stenting in PCI is based on 4 studies that have demonstrated the usefulness of bare metal stents in patients with STEMI. However this recommendation cannot be extrapolated (yet) to the use of drug eluting stents. Although DES have been used widely in unstable angina and in acute myocardial infarction, to date there are no evidence-based recommendations to support the routine use of DES in STEMI.

GPI have been studied extensively in patients with non-STsegment elevation myocardial infarctions (NSTEMI) with planned or performed PCI. In STEMI tirofiban and and eptifibatide are less well investigated, and only abciximab is recommended in primary PCI, but the long term benefits require more investigation. In PCI randomized controlled clinical trials (RCT's) abciximab consistently showed a significant reduction in the rate of myocardial infarction and the need for urgent revascularization. Abciximab has been evaluated in 5 RCT's in association with primary PCI. The pooled analysis for the clinical outcome at 30 days, demonstrate a significant reduction of death, re- infarction and target vessel revascularization (TVR), mainly due to a reduction of repeat intervention. The long-term benefits require more investigation.

The DEBATER trial is designed to answer the questions about the need for abciximab and about the use of DES in primary PCI. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00986050
Study type	Interventional
Source	Catharina Ziekenhuis Eindhoven
Contact
Status	Completed
Phase	Phase 4
Start date	January 2006
Completion date	July 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction — DEBATER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms