Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial (Brave-2)
September 24, 2008 updated by: Deutsches Herzzentrum Muenchen
An International, Multicenter, Randomized Trial Assessing the Value of Mechanical Reperfusion in Patients With Acute Myocardial Infarction Presenting > 12 Hours From Onset of Symptoms
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
365
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Feldkirch, Austria
- Landeskrankenhaus Feldkirch
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Bad Reichenhall, Germany
- Staedtisches Krankenhaus Bad Reichenhall
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Erding, Germany, 85435
- Kreiskrankenhaus Erding/Dorfen
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Freilassing, Germany
- Kreiskrankenhaus Freilassing
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Fuerstenfeldbruck, Germany
- Kreisklinik Fuerstenfeldbruck
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Garmisch-Partenkirchen, Germany, 82467
- Klinikum Garmisch-Partenkirchen
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Munich, Germany, 80636
- Deutsches Herzzentrum Muenchen
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Munich, Germany, 81675
- 1st Medizinische Klinik, Klinikum rechts der Isar
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Ruhpolding, Germany
- Krankenhaus Vinzentinum Ruhpolding
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Schongau, Germany
- Krankenhaus Schongau
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Traunstein, Germany, 83278
- Klinikum Traunstein
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Trostberg, Germany
- Kreisklinik Trostberg
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Florence, Italy
- Azienda Ospedaliera Careggi
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Mestre, Italy
- Ospedale, "Umberto I"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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5-10 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2001
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
September 24, 2008
First Submitted That Met QC Criteria
September 24, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
September 25, 2008
Last Update Submitted That Met QC Criteria
September 24, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GE IDE No. I00800
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.