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

July 25, 2011 updated by: Catharina Ziekenhuis Eindhoven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

907

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Brabant
      • Eindhoven, Brabant, Netherlands
        • Catharina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bare metal stent (BMS)
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
Active Comparator: Drug eluting stent (DES)
Device: drug eluting stent (sirolimus eluting) - CYPHER stent
stent implantation in culprit artery in acute myocardial infarction
Other Names:
  • CYPHER stent
Active Comparator: Abciximab
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
No Intervention: No abciximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
target vessel failure
Time Frame: 30 days and one year
30 days and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac and cerebral adverse events ( MACCE)
Time Frame: 30 days and one year
30 days and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Compusense Oegstgeest ( electronic randomization and CRF)
CATHREINE ( data monitoring)

Investigators

  • Principal Investigator: Rolf Michels, Catharina Ziekenhuis Eindhoven
  • Principal Investigator: Inge Wijnbergen, Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CATHREINE-DEBATER 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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