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

Acute Myocardial Infarction Clinical Trial

— DEBATER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986050
• Other study ID #: CATHREINE-DEBATER 2006
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2009
• Last updated: July 25, 2011
• Start date: January 2006
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: July 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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
• drug eluting stent (sirolimus eluting) - CYPHER stent
stent implantation in culprit artery in acute myocardial infarction

Locations

Country	Name	City	State
Netherlands	Catharina ziekenhuis	Eindhoven	Brabant

Sponsors (4)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), CATHREINE ( data monitoring), Compusense Oegstgeest ( electronic randomization and CRF)

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansiéri 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. — View Citation

Schömig A, Schmitt C, Dibra A, Mehilli J, Volmer C, Schühlen 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. Epub 2005 Feb 25. — View Citation

Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen 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. Epub 2005 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target vessel failure		30 days and one year	Yes
Secondary	Major adverse cardiac and cerebral adverse events ( MACCE)		30 days and one year	Yes