Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

May 31, 2001

Primary Completion Date

January 31, 2005

Study Completion Date

August 31, 2005

Conditions
Myocardial Infarction
Interventions
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.

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

Trial Locations (14)

80636

Deutsches Herzzentrum Muenchen, Munich

81675

1st Medizinische Klinik, Klinikum rechts der Isar, Munich

82467

Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen

83278

Klinikum Traunstein, Traunstein

85435

Kreiskrankenhaus Erding/Dorfen, Erding

Unknown

Landeskrankenhaus Feldkirch, Feldkirch

Staedtisches Krankenhaus Bad Reichenhall, Bad Reichenhall

Kreiskrankenhaus Freilassing, Freilassing

Kreisklinik Fuerstenfeldbruck, Fürstenfeldbruck

Krankenhaus Vinzentinum Ruhpolding, Ruhpolding

Krankenhaus Schongau, Schongau

Kreisklinik Trostberg, Trostberg an der Alz

Azienda Ospedaliera Careggi, Florence

"Ospedale, Umberto I", Mestre

All Listed Sponsors
collaborator

Technical University of Munich

OTHER

lead

Deutsches Herzzentrum Muenchen

OTHER

NCT00759629 - Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial | Biotech Hunter | Biotech Hunter