Organization to Assess Strategies for Ischemic Syndromes – Pilot
To compare hirudin vs. heparin administered as a 72 hour infusion post presentation and warfarin vs. standard therapy for 6 months in patients with ST segment elevation acute coronary syndromes. Hirudin, especially at the medium dose, was superior to heparin in preventing ischemic outcomes there was a reduction in the rate of recurrent ischemic events with moderate-intensity, but not with low intensity warfarin. There was an excess in minor bleeds in the warfarin group.
Controlled trial, evaluated 2 doses of hirudin and warfarin a 3×2 design.
Primary endpoint: the composite of CV death, new MI, or refractory angina; Secondary endpoint: the composite of CV death, new MI, refractory angina, or severe angina and the composite of CV death, new MI, or severe angina requiring revascularization procedures within 7 days and CV death MI, or stroke at 6 months for the warfarin arm. Bleeding rates were also evaluated. Key endpoints were adjudicated.