Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial

NCT00759629 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. I00800
• Study Type: interventional
• Target: 365
• Locations: 3 countries
• Sites: 14

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

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study is the infarct size calculated as the final perfusion defect (% of left ventricle) at the scintigraphic study

  5-10 days

Secondary Outcomes (1)

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

  30 days

Study Arms (2)

A

EXPERIMENTAL

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

B

ACTIVE COMPARATOR

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

Interventions

Interventional treatment group OTHER

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.

A

Conservative treatment group OTHER

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

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Technical University of Munich: collaborator

Study Sites (14)

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Location

Staedtisches Krankenhaus Bad Reichenhall

Bad Reichenhall, Germany

Location

Kreiskrankenhaus Erding/Dorfen

Erding, 85435, Germany

Location

Kreiskrankenhaus Freilassing

Freilassing, Germany

Location

Kreisklinik Fuerstenfeldbruck

Fürstenfeldbruck, Germany

Location

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, 82467, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

1st Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Krankenhaus Vinzentinum Ruhpolding

Ruhpolding, Germany

Location

Krankenhaus Schongau

Schongau, Germany

Location

Klinikum Traunstein

Traunstein, 83278, Germany

Location

Kreisklinik Trostberg

Trostberg an der Alz, Germany

Location

Azienda Ospedaliera Careggi

Florence, Italy

Location

Ospedale, "Umberto I"

Mestre, Italy

Location

Related Publications (1)

• 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.

  PMID: 15956631 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Albert Schoemig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: May 1, 2001
• Primary Completion: January 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

DE (11); AU (1); IT (2)