Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00133250
First received: August 20, 2005
Last updated: March 15, 2010
Last verified: March 2010

August 20, 2005
March 15, 2010
June 2003
February 2008   (final data collection date for primary outcome measure)
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 ]
Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study.
Complete list of historical versions of study NCT00133250 on ClinicalTrials.gov Archive Site
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 ]
  • Clinical adverse events (death of any cause, reinfarction, stroke;
  • urgent reinterventions;
  • major and minor bleeding complications
  • thrombocytopenia <20 x 109 /L)
Not Provided
Not Provided
 
Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
Value of Abciximab in Patients With AMI Undergoing PCI After High Dose 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: Abciximab
    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
  • 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.
  • Experimental: A
    Abciximab
    Intervention: Drug: Abciximab
  • Placebo Comparator: B
    Heparin Sodium
    Intervention: Other: Placebo Heparin Sodium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
March 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients presenting with ST-Elevation acute myocardial infarction within 24 hours from the onset of symptoms

Exclusion Criteria:

  • Age >80 years
  • Malignancies
  • Cardiogenic shock
  • Prolonged cardio-pulmonary resuscitation
  • Increased risk of bleeding
  • Relevant hematologic deviations (hemoglobin <100 g/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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00133250
GE IDE No. I00902
Yes
Prof. A. Schömig, Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Technische Universität München
Study Chair: Albert Schomig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP