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

This study has been completed.
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Compusense Oegstgeest ( electronic randomization and CRF)
CATHREINE ( data monitoring)
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00986050
First received: September 9, 2009
Last updated: July 25, 2011
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Abciximab
Device: bare metal stent prokinetic, chrono, skylor or bluemedical
Device: drug eluting stent (sirolimus eluting) - CYPHER stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study

Resource links provided by NLM:


Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • target vessel failure [ Time Frame: 30 days and one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Major adverse cardiac and cerebral adverse events ( MACCE) [ Time Frame: 30 days and one year ] [ Designated as safety issue: Yes ]

Enrollment: 907
Study Start Date: January 2006
Study Completion Date: July 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: reopro
No Intervention: No abciximab

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986050

Locations
Netherlands
Catharina ziekenhuis
Eindhoven, Brabant, Netherlands
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antoinette Spierings, CATHREINE
ClinicalTrials.gov Identifier: NCT00986050     History of Changes
Other Study ID Numbers: CATHREINE-DEBATER 2006
Study First Received: September 9, 2009
Last Updated: July 25, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
STEMI
DES
BMS
abciximab

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Abciximab
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticoagulants
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014