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

Conditions: Patients with ACS who are scheduled for primary PCI (STEMI) or for immediate PCI < 2.5 hours or early PCI < 48 hours (NSTEMI) and who are pre-treated with HLD clopidogrel

Registration Number: EUCTR2010-023779-24-NL

Lead Sponsor: Stichting Toegepast Caridologisch Onderzoek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1800

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)
New left bundle branch block (LBBB)
Old LBBB or paced rhythm with:
ST-segment elevation > 5 mm in right precordial leads V1-V3 (discordant with QRS)
ST-segment depression/T wave inversion V1-V3
ST-segment elevation = 1 mm concordant with a large R wave

Criteria for high-risk NSTEMI

Patients with recurrent ischemia/chest pain
Dynamic ECG changes (ST-segment depression or transient ST-segment elevation)
Elevated troponin levels
Early post infarction unstable angina
Diabetes
Hemodynamic instability
Major arrhythmias (VF, VT)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
Patients who are already included in DEBATER II or in other trials