Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial (Brave-2)

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Other: Conservative treatment group; Other: Interventional treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT00759629

GE IDE No. I00800

Details and patient eligibility

About

The objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with AMI presenting between 12 and 48 hours after onset of symptoms compared to medical treatment alone

Full description

Between 8.5% and 40% of patients with acute myocardial infarction present late after symptom onset, no longer being eligible for thrombolysis.Despite efforts to reduce time to presentation, recent studies have demonstrated that time-to-arrival has not changed.The lack of efficacy of thrombolysis in patients with acute MI presenting > 12 hours after symptom onset may be a reason why current guidelines oppose reperfusion therapy in this setting.Several findings suggest, however,that reperfusion therapy may be beneficial even among these patients. First, recent studies have shown that viable salvageable myocardium exists even after >12 hours of severe ischemia. Second, previous studies have not only demonstrated that PCI is better than thrombolysis in patients with acute MI,but also that the time window of efficacy for PCI may be wider than that for thrombolysis.Third, observational studies suggest that PCI is effective even when performed after 12 hours from symptom onset in patients with acute MI. The goal of our trial was to assess whether an invasive strategy based on PCI with stenting is associated with reduction of infarct size in patients with acute STEMI presenting > 12 hours after symptom onset compared with a conventional conservative treatment strategy.

Enrollment: 365 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients fulfilling the criteria of AMI and presenting at the hospital between 12 and 48 hours after onset of symptoms. The criteria of AMI are fulfilled when at least one episode of typical chest pain lasting ≥ 20 minutes is combined with either unequivocal ECG changes (≥ 0.1 mV of ST-segment elevation in ≥ 2 limb leads or ≥ 0.2 mV in ≥ 2 contiguous precordial leads or new pathological Q-waves) or CK plus concomitant CK-MB increase above twice the upper normal threshold. All patients have to be informed of the nature of the study and should give their informed consent for participation in the study.

Exclusion criteria

• Age <18 years and > 80 years
• Cardiogenic shock (systolic blood pressure < 80 mm Hg unresponsive to fluids or necessitating the infusion of catecholamines: GUSTO I criteria)
• Persistent severe chest pain
• Prior thrombolysis (for index AMI)
• Malignancies with life expectancy < 1year
• History of bleeding diathesis, coagulopathy
• Contraindications to the antithrombotic therapy used in conjunction with coronary stenting (clopidogrel and abciximab)
• Stroke within the past 3 months
• Major surgery within the past 30 days
• Platelets < 100000/mm3 or >700000/mm3, Hb < 10g/dl, white blood cell count <3000/mm3
• Percutaneous coronary intervention within the past 30 days
• Inability to cooperate with study procedures and/or follow-up
• Previous enrollment in this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 2 patient groups

A

Experimental group

Description:

Interventional treatment group - Patients assigned to PCI will receive the loading dose of clopidogrel, aspirin plus a bolus of heparin and be transferred immediately for interventional treatment. They will receive abciximab as a bolus followed by a continuous infusion of for 12 hours.

Treatment:

Other: Interventional treatment group

B

Active Comparator group

Description:

Conservative treatment group - Patients assigned to this group will receive the usual therapy in the intensive care unit of the admitting hospital according to local standards.

Treatment:

Other: Conservative treatment group