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

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Other: Placebo Heparin Sodium; Drug: Abciximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00133250

GE IDE No. I00902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

800 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Abciximab

Treatment:

Drug: Abciximab

B

Placebo Comparator group

Description:

Heparin Sodium

Treatment:

Other: Placebo Heparin Sodium