EUCTR2010-023779-24-NL
Active, not recruiting
Not Applicable
A Comparison of Drug Eluting and Bare Metal Stents with Bivalirudin during PCI or Bivalirudin for 4 hours in Acute Coronary Syndromes. The Eindhoven Reperfusion Study - The DEBATER 2 Trial
Stichting Toegepast Caridologisch Onderzoek0 sites1,800 target enrollmentNovember 11, 2010
DrugsAngiox
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stichting Toegepast Caridologisch Onderzoek
- Enrollment
- 1800
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •STEMI \< 12 hours (or STE equivalent), or NSTEMI \< 48 hours
- •No contraindications for PCI
- •No contraindications for abciximab
- •No contraindications for clopidogrel
- •Informed consent from the patient
- •Criteria for STEMI \< 12 hours (or STE equivalent)
- •Continual chest discomfort of acute onset within the last 12 hours
- •\= 1 mm ST\-segment elevation in \= 2 contiguous ECG leads
- •STE equivalent
- •\= 1 mm ST\-segment depression in ECG leads V1\-V3 (reversed ST\-segment elevations of the posterior wall)
Exclusion Criteria
- •Contraindication for PCI: peripheral/coronary artery disease that is inaccessible for PCI
- •Contraindication for GPI: ongoing bleeding, bleeding diathesis, cerebrovascular accident in the last 6 months, major surgery/trauma in the last 6 months, platelet count \< 100\.000 mm3, intracranial intravenous malformation or neoplasm, malignant hypertension, INR . 1\.5, severe hepatic dysfunction
- •Contraindication for bivalirudin: bleeding diathesis, thrombocytopathy, thrombocytopenia, coagulopathy, recent surgery, TIA or CVA, severe uncontrolled hypertension, active peptic ulcer, severe renal insufficiency (MDRD \< 30 ml/min).
- •Contraindication for clopidogrel: severe hepatic dysfunction, pathological bleeding
- •disorders such as peptic ulcer or intracranial bleeding
- •Thrombolytic therapy within the last 24 hours
- •Therapy with GPI within the last 24 hours
- •Anticoagulation therapy
- •C\-morbid conditions with a predictable fatal outcome in the short run
- •No informed consent: refusal, (sub) coma, artificial respiration, impaired mentation
Outcomes
Primary Outcomes
Not specified
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