Status:
COMPLETED
Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Compusense Oegstgeest ( electronic randomization and CRF)
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
Phase:
PHASE4
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 myocardi...
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...
Eligibility Criteria
Inclusion
- STEMI ≤ 12 hours (or STEMI equivalent).
- No contra - indications for primary PCI.
- No contra - indications for abciximab.
- Informed consent from the patient.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
907 Patients enrolled
Trial Details
Trial ID
NCT00986050
Start Date
January 1 2006
End Date
July 1 2009
Last Update
July 26 2011
Active Locations (1)
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1
Catharina ziekenhuis
Eindhoven, North Brabant, Netherlands