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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); CATHREINE ( data monitoring); Compusense Oegstgeest ( electronic randomization and CRF)
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments; Sirolimus

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.