365
Participants
Start Date
May 31, 2001
Primary Completion Date
January 31, 2005
Study Completion Date
August 31, 2005
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.
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
Deutsches Herzzentrum Muenchen, Munich
1st Medizinische Klinik, Klinikum rechts der Isar, Munich
Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen
Klinikum Traunstein, Traunstein
Kreiskrankenhaus Erding/Dorfen, Erding
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
Technical University of Munich
OTHER
Deutsches Herzzentrum Muenchen
OTHER