Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction
DEBATER
A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study
1 other identifier
interventional
907
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedJuly 26, 2011
September 1, 2009
2.3 years
September 9, 2009
July 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
target vessel failure
30 days and one year
Secondary Outcomes (1)
Major adverse cardiac and cerebral adverse events ( MACCE)
30 days and one year
Study Arms (4)
Bare metal stent (BMS)
ACTIVE COMPARATORDrug eluting stent (DES)
ACTIVE COMPARATORAbciximab
ACTIVE COMPARATORNo abciximab
NO INTERVENTIONInterventions
Abciximab bolus 0,25mg/kg, 10-60 minutes before PCI. Infusion 0,125ug/kg/min for 12 hours after PCI.
bare metal stent in culprit artery in acute myocardial infarction
stent implantation in culprit artery in acute myocardial infarction
Eligibility Criteria
You may qualify if:
- STEMI ≤ 12 hours (or STEMI equivalent).
- No contra - indications for primary PCI.
- No contra - indications for abciximab.
- Informed consent from the patient.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catharina ziekenhuis
Eindhoven, North Brabant, Netherlands
Related Publications (4)
Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.
PMID: 15769784BACKGROUNDMontalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansieri M, Choussat R, Pinton P; ADMIRAL Investigators. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001 Jun 21;344(25):1895-903. doi: 10.1056/NEJM200106213442503.
PMID: 11419426BACKGROUNDSchomig A, Schmitt C, Dibra A, Mehilli J, Volmer C, Schuhlen H, Dirschinger J, Dotzer F, ten Berg JM, Neumann FJ, Berger PB, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators. One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel. Eur Heart J. 2005 Jul;26(14):1379-84. doi: 10.1093/eurheartj/ehi174. Epub 2005 Feb 25.
PMID: 15734767BACKGROUNDWijnbergen I, Helmes H, Tijssen J, Brueren G, Peels K, van Dantzig JM, Van' t Veer M, Koolen JJ, Pijls NH, Michels R. Comparison of drug-eluting and bare-metal stents for primary percutaneous coronary intervention with or without abciximab in ST-segment elevation myocardial infarction: DEBATER: the Eindhoven reperfusion study. JACC Cardiovasc Interv. 2012 Mar;5(3):313-22. doi: 10.1016/j.jcin.2011.11.009.
PMID: 22440498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf Michels
Catharina Ziekenhuis Eindhoven
- PRINCIPAL INVESTIGATOR
Inge Wijnbergen
Catharina Ziekenhuis Eindhoven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 29, 2009
Study Start
January 1, 2006
Primary Completion
May 1, 2008
Study Completion
July 1, 2009
Last Updated
July 26, 2011
Record last verified: 2009-09