LONG-TERM LOW-MOLECULAR-WEIGHT HEPARIN (FRAGMIN) AND OR EARLY REVASCULARIZATION DURING INSTABILITY IN CORONARY-ARTERY DISEASE (THE FRISC-IISTUDY)/

The Fragmin and/or Early Revascularisation during Instability in Coron ary Artery Disease (FRISC II) trial will, in a prospective multicenter factorially randomized study, compare the efficacy of 3 months contin uation of subcutaneous treatment with the low-molecular-weight heparin dalteparin (Fragmin) with that of placebo and will also compare a dir ect invasive strategy with a stepwise selective approach with regard t o the utilization of coronary angiography and revascularization in pat ients with unstable coronary artery disease. The primary end-points ar e death or myocardial infarction after 3 and 6 months respectively. Se condary endpoints are the same events after 12-24 months and also card iac symptoms, exercise capacity, and/or signs of myocardial ischemia, readmission, and costs. Analyses will also be made of subgroups based on inclusion diagnosis, initial elevation of biochemical markers of my ocardial damage, elevation of fibrinogen or C-reactive protein, signs of ischemia in electrocardiography at rest or at continuous 24-hour is chemia monitoring, and left ventricular function at echocardiography. Altogether, 3,100 patients will be recruited in 65-70 Scandinavian cen ters. Completion of follow-up is anticipated in the second half of 199 8. The FRISC II study will further elucidate new alternatives for anti thrombotic, invasive, and individually tailored treatment of unstable coronary syndromes. (C) 1997 by Excerpta Medica, Inc.