Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.

      Comparison:

      Abciximab (bolus+infusion for 12h) versus Placebo (bolus+infusion for 12h) after
      pre-treatment with 600 mg clopidogrel.
    

Intervention name(s): Abciximab; Placebo Heparin Sodium
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Other intervention name(s): ReoPro
Intervention MeSH terms: Heparin; Calcium heparin; Abciximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment