Clinical trial NCT00759629: Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial
Official title: An International, Multicenter, Randomized Trial Assessing the Value of Mechanical Reperfusion in Patients With Acute Myocardial Infarction Presenting > 12 Hours From Onset of Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2008-09-25
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint of the study is the infarct size calculated as the final perfusion defect (% of left ventricle) at the scintigraphic study
timeFrame: 5-10 days
Secondary outcomes:
measure: Secondary endpoint of the study is the composite of all-cause death, recurrent MI, or stroke within 30 days after randomization.
timeFrame: 30 days
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Bad Reichenhall
country: Germany
facility: Staedtisches Krankenhaus Bad Reichenhall
city: Erding
country: Germany
facility: Kreiskrankenhaus Erding/Dorfen
city: Freilassing
country: Germany
facility: Kreiskrankenhaus Freilassing
city: Fuerstenfeldbruck
country: Germany
facility: Kreisklinik Fuerstenfeldbruck
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: 1st Medizinische Klinik, Klinikum rechts der Isar
city: Ruhpolding
country: Germany
facility: Krankenhaus Vinzentinum Ruhpolding
city: Schongau
country: Germany
facility: Krankenhaus Schongau
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Trostberg
country: Germany
facility: Kreisklinik Trostberg
city: Florence
country: Italy
facility: Azienda Ospedaliera Careggi
city: Mestre
country: Italy
facility: Ospedale, "Umberto I"
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Albert Schoemig, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schomig A, Mehilli J, Antoniucci D, Ndrepepa G, Markwardt C, Di Pede F, Nekolla SG, Schlotterbeck K, Schuhlen H, Pache J, Seyfarth M, Martinoff S, Benzer W, Schmitt C, Dirschinger J, Schwaiger M, Kastrati A; Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators. Mechanical reperfusion in patients with acute myocardial infarction presenting more than 12 hours from symptom onset: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2865-72. doi: 10.1001/jama.293.23.2865.