Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: Abciximab Other: Placebo Heparin Sodium |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 800 |
| Study Start Date: | June 2003 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Abciximab
|
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
|
|
Placebo Comparator: B
Heparin Sodium
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Austria | |
| Allgemeines Krankenhaus Wien | |
| Vienna, Austria, 1090 | |
| Germany | |
| Klinikum Garmisch-Partenkirchen | |
| Garmisch-Partenkirchen, Germany, 82467 | |
| Deutsches Herzzentrum Muenchen | |
| Munich, Germany, 80636 | |
| First Medizinische Klinik, Klinikum rechts der Isar | |
| Munich, Germany, 81675 | |
| Klinikum Traunstein | |
| Traunstein, Germany, 83278 | |
| Study Chair: | Albert Schomig, MD | Deutsches Herzzentrum Muenchen |
| Principal Investigator: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. A. Schömig, Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00133250 History of Changes |
| Other Study ID Numbers: | GE IDE No. I00902 |
| Study First Received: | August 20, 2005 |
| Last Updated: | March 15, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Calcium heparin Abciximab Heparin Clopidogrel Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013