Trial | NCT00986050  Report issue

Title

Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction
A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    abciximab sirolimus ...

  • Study Participants

    907
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.
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 Started
Jan 31
2006
Primary Completion
May 31
2008
Study Completion
Jul 31
2009
Last Update
Jul 26
2011
Estimate

Drug Abciximab

Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.

  • Other names: reopro

Device bare metal stent prokinetic, chrono, skylor or bluemedical

bare metal stent in culprit artery in acute myocardial infarction

  • Other names: operator-dependent: prokinetic, chrono, skylor, bluemedical

Device drug eluting stent (sirolimus eluting) - CYPHER stent

stent implantation in culprit artery in acute myocardial infarction

  • Other names: CYPHER stent

Bare metal stent (BMS) Active Comparator

Drug eluting stent (DES) Active Comparator

Abciximab Active Comparator

No abciximab No Intervention

Criteria 

Inclusion Criteria:

STEMI ≤ 12 hours (or STEMI equivalent).
No contra - indications for primary PCI.
No contra - indications for abciximab.
Informed consent from the patient.

Exclusion Criteria:

Contra - indication for primary PCI: History of peripheral/coronary artery disease that is inaccessible for angiography or PCI.
Contra - indications for GPI: Ongoing bleeding, bleeding diathesis, cerebrovascular accident < 6 months, major surgery/trauma < 6 months, platelet count < 100.000 mm3 , intracranial arteriovenous malformation or neoplasm, malignant hypertension, INR >1.5, severe hepatic dysfunction

Contra - indications for clopidogrel:

Severe liver dysfunction, pathological bleeding disorders such as peptic ulcer or intracranial bleeding.
Thrombolytic therapy < 24 hours.
Therapy with GPI < 24 hours.
Anticoagulation therapy.
Co - morbid conditions with a predictable fatal outcome in the short run.
No informed consent: refusal, coma, artificial respiration, impaired mentation.
No Results Posted