Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.

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

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Collaborator: Technische Universität München
• Treatments: Abciximab; Antibodies, Monoclonal; Clopidogrel; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Patients with acute coronary syndromes

• Pretreatment (2 hours) with high loading dose (600 mg) clopidogrel

• Significant angiographic lesions amenable to and requiring a PCI

• Written informed consent

Exclusion Criteria:

• ST-segment elevation acute myocardial infarction within 48 hours from symptom onset

• Hemodynamic instability

• Pericarditis

• Malignancies with life expectancy less than one year

• Increased risk of bleeding

• Oral anticoagulation therapy with coumarin derivative within 7 days

• Recent use of GPIIb/IIIa inhibitors within 14 days

• Severe uncontrolled hypertension >180 mmHg unresponsive to therapy

• Relevant hematologic deviations: hemoglobin < 100g/L or hematocrit < 34%; platelet count < 100 x 10^9/L or platelet count > 600 x 10^9/L.

• Known allergy to the study medication

• Pregnancy (present or suspected)