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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3)

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Abciximab
* Other: Placebo Heparin Sodium


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Abciximab | Drug: Abciximab<br>* 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.<br>* Other names: ReoPro;|
| Placebo Comparator: B<br>Heparin Sodium | Other: Placebo Heparin Sodium<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular infarct size calculated as the final perfusion defect at follow-up scintigraphic study |  | 5-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical adverse events (death of any cause, reinfarction, stroke, urgent reinterventions, major and minor bleeding complications, thrombocytopenia <20 x 10^9 /L) |  | 30 days |