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

This study has been completed.
Sponsor:
Collaborator:
Technische Universität München
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00759629
First received: September 24, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Myocardial Infarction
Other: Interventional treatment group
Other: Conservative treatment group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • The primary endpoint of the study is the infarct size calculated as the final perfusion defect (% of left ventricle) at the scintigraphic study [ Time Frame: 5-10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoint of the study is the composite of all-cause death, recurrent MI, or stroke within 30 days after randomization. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 365
Study Start Date: May 2001
Study Completion Date: August 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Other: Interventional treatment group
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.
Active Comparator: B
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.
Other: 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. 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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759629

Locations
Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Germany
Staedtisches Krankenhaus Bad Reichenhall
Bad Reichenhall, Germany
Kreiskrankenhaus Erding/Dorfen
Erding, Germany, 85435
Kreiskrankenhaus Freilassing
Freilassing, Germany
Kreisklinik Fuerstenfeldbruck
Fuerstenfeldbruck, Germany
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany, 82467
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
1st Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Krankenhaus Vinzentinum Ruhpolding
Ruhpolding, Germany
Krankenhaus Schongau
Schongau, Germany
Klinikum Traunstein
Traunstein, Germany, 83278
Kreisklinik Trostberg
Trostberg, Germany
Italy
Azienda Ospedaliera Careggi
Florence, Italy
Ospedale, "Umberto I"
Mestre, Italy
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Technische Universität München
Investigators
Study Chair: Albert Schoemig, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00759629     History of Changes
Other Study ID Numbers: GE IDE No. I00800
Study First Received: September 24, 2008
Last Updated: September 24, 2008
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014