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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Interventional treatment group
Conservative treatment group
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Landeskrankenhaus Feldkirch
  • Staedtisches Krankenhaus Bad Reichenhall
  • Kreiskrankenhaus Erding/Dorfen
  • Kreiskrankenhaus Freilassing
  • Kreisklinik Fuerstenfeldbruck
  • Klinikum Garmisch-Partenkirchen
  • Deutsches Herzzentrum Muenchen
  • 1st Medizinische Klinik, Klinikum rechts der Isar
  • Krankenhaus Vinzentinum Ruhpolding
  • Krankenhaus Schongau
  • Klinikum Traunstein
  • Kreisklinik Trostberg
  • Azienda Ospedaliera Careggi
  • Ospedale, "Umberto I"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm 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.

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.

Outcomes

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

Secondary Outcome Measures

Secondary endpoint of the study is the composite of all-cause death, recurrent MI, or stroke within 30 days after randomization.

Full Information

First Posted
September 24, 2008
Last Updated
September 24, 2008
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00759629
Brief Title
Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial
Acronym
Brave-2
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Technical University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm 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.
Arm Title
B
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Interventional treatment group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conservative treatment group
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Schoemig, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
Country
Austria
Facility Name
Staedtisches Krankenhaus Bad Reichenhall
City
Bad Reichenhall
Country
Germany
Facility Name
Kreiskrankenhaus Erding/Dorfen
City
Erding
ZIP/Postal Code
85435
Country
Germany
Facility Name
Kreiskrankenhaus Freilassing
City
Freilassing
Country
Germany
Facility Name
Kreisklinik Fuerstenfeldbruck
City
Fuerstenfeldbruck
Country
Germany
Facility Name
Klinikum Garmisch-Partenkirchen
City
Garmisch-Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
1st Medizinische Klinik, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Krankenhaus Vinzentinum Ruhpolding
City
Ruhpolding
Country
Germany
Facility Name
Krankenhaus Schongau
City
Schongau
Country
Germany
Facility Name
Klinikum Traunstein
City
Traunstein
ZIP/Postal Code
83278
Country
Germany
Facility Name
Kreisklinik Trostberg
City
Trostberg
Country
Germany
Facility Name
Azienda Ospedaliera Careggi
City
Florence
Country
Italy
Facility Name
Ospedale, "Umberto I"
City
Mestre
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15956631
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.
Results Reference
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Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial

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