Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
The purpose of this study is to assess whether abciximab is associated with additional benefit in patients with AMI treated with PCI after high dose clopidogrel loading.
Other: Placebo Heparin Sodium
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3)|
- Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study [ Time Frame: 5-7 days ] [ Designated as safety issue: No ]
- Clinical adverse events (death of any cause, reinfarction, stroke, urgent reinterventions, major and minor bleeding complications, thrombocytopenia <20 x 10^9 /L) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||March 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Abciximab bolus and infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 10 mg abciximab. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
Other Name: ReoPro
Placebo Comparator: B
Other: Placebo Heparin Sodium
Placebo bolus plus infusion is given. Study medication includes 3 identical vials, each with 5 ml solution containing 3000 U Heparin. The bolus dose to be given should be rated at 0.125 ml/kg of patient's weight. After the bolus, a total dose of 0.045 ml/kg study substance (up to a maximal quantity of 3.6 ml) should be given over 12 hours.
The goal of all reperfusion therapies in acute myocardial infarction (AMI) is an effective restoration of coronary blood flow and the reduction of infarct size. Recently, the researchers were able to achieve excellent results with primary stenting plus abciximab in terms of reduction of infarct size and improvement of clinical outcome in the STOPAMI trial. This strategy provided a clear benefit compared to fibrinolysis. On the basis of the data published in the last 2 years, hospitals without angioplasty facilities have now better possibilities to improve the results of primary treatment of patients with AMI by immediately referring these patients to highly experienced centers in coronary interventions. There is an increasing interest to assess the additional advantages of pharmacologic reperfusion approaches which are readily applicable in the time window between presentation and arrival at the catheterization room. Two studies have shown that the results of the PCI in patients with AMI pretreated with fibrinolysis may even be more unfavorable than those achieved with angioplasty alone. Glycoprotein (GP) IIb/IIIa blocker abciximab has been shown to improve the results of the primary PCI in AMI. However, no rapidly effective antiplatelets therapy was available at the time when the studies on the benefit of abciximab were performed. Recent studies have shown that a high, 600 mg loading dose of clopidogrel is significantly more rapidly acting and that maximal inhibition of platelet aggregation is achieved within 2 hours after administration. In the ISAR-REACT trial, a high loading dose of clopidogrel was well tolerated, associated with such a low frequency of procedural complications that the use of abciximab offered no clinically measurable benefit at 30 days.
Abciximab (bolus+infusion for 12h) versus Placebo (bolus+infusion for 12h) after pre-treatment with 600 mg clopidogrel.
|Allgemeines Krankenhaus Wien|
|Vienna, Austria, 1090|
|Garmisch-Partenkirchen, Germany, 82467|
|Deutsches Herzzentrum Muenchen|
|Munich, Germany, 80636|
|First Medizinische Klinik, Klinikum rechts der Isar|
|Munich, Germany, 81675|
|Traunstein, Germany, 83278|
|Study Chair:||Albert Schomig, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Adnan Kastrati, MD||Deutsches Herzzentrum Muenchen|