Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed 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.
    

Intervention name(s): Interventional treatment group; Conservative treatment group
Intervention type(s): Other; Other
Intervention description(s): Patients assigned to PCI will receive the loading dose of clopidogrel (300 mg), 500 mg aspirin plus a bolus of 70 U/kg heparin i.v. and be transferred immediately for interventional treatment. They will receive abciximab as a bolus of 0.25 mg/Kg of body weight followed by a continuous infusion of 0.125 µg/Kg/minute (up to a maximal dose of 10 µg/minute) for 12 hours. All patients will undergo coronary angiography and left ventriculography in the conventional way. During the procedure patients will receive the weight-adjusted heparin doses (70 U/ kg). Post-procedural antithrombotic therapy will consist of clopidogrel in a daily dose of 75 mg for at least 4 weeks (6 months recommended) and aspirin, 100 mg to 350 mg daily, indefinitely.; Patients assigned to this group will receive the usual therapy in the intensive care unit of the admitting hospital according to local standards. Per protocol, all patients in this arm will receive a loading dose of clopidogrel (300 mg) followed by 75 mg/day for at least 4 weeks (6 months recommended) after randomization and aspirin, indefinitely. Recommended additional regimen will include heparin, ß-blockers, ACE inhibitors and statins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment