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

NCT00986050 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 907

Last updated 2011-07-26

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Abciximab

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

DEVICE

bare metal stent prokinetic, chrono, skylor or bluemedical

bare metal stent in culprit artery in acute myocardial infarction

DEVICE

drug eluting stent (sirolimus eluting) - CYPHER stent

stent implantation in culprit artery in acute myocardial infarction

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Compusense Oegstgeest ( electronic randomization and CRF)

    collaborator UNKNOWN

  • CATHREINE ( data monitoring)

    collaborator UNKNOWN

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Principal Investigators

  • Rolf Michels · Catharina Ziekenhuis Eindhoven

  • Inge Wijnbergen · Catharina Ziekenhuis Eindhoven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-05-31
Completion
2009-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00986050 on ClinicalTrials.gov