Long-term low-molecular-weight heparin (Fragmin) and/or early revascularization during instability in coronary artery disease (the FRISC II Study)

Am J Cardiol. 1997 Sep 4;80(5A):61E-63E. doi: 10.1016/s0002-9149(97)00493-1.

Abstract

The Fragmin and/or Early Revascularisation during Instability in Coronary Artery Disease (FRISC II) trial will, in a prospective multicenter factorially randomized study, compare the efficacy of 3 months continuation of subcutaneous treatment with the low-molecular-weight heparin dalteparin (Fragmin) with that of placebo and will also compare a direct invasive strategy with a stepwise selective approach with regard to the utilization of coronary angiography and revascularization in patients with unstable coronary artery disease. The primary endpoints are death or myocardial infarction after 3 and 6 months respectively. Secondary endpoints are the same events after 12-24 months and also cardiac 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 myocardial damage, elevation of fibrinogen or C-reactive protein, signs of ischemia in electrocardiography at rest or at continuous 24-hour ischemia monitoring, and left ventricular function at echocardiography. Altogether, 3,100 patients will be recruited in 65-70 Scandinavian centers. Completion of follow-up is anticipated in the second half of 1998. The FRISC II study will further elucidate new alternatives for antithrombotic, invasive, and individually tailored treatment of unstable coronary syndromes.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Angina, Unstable / drug therapy
  • Anticoagulants / administration & dosage
  • Anticoagulants / therapeutic use*
  • Coronary Angiography
  • Coronary Disease / drug therapy*
  • Coronary Disease / surgery
  • Dalteparin / administration & dosage
  • Dalteparin / therapeutic use*
  • Drug Therapy, Combination
  • Humans
  • Myocardial Infarction / drug therapy
  • Myocardial Revascularization
  • Randomized Controlled Trials as Topic
  • Thrombolytic Therapy*

Substances

  • Anticoagulants
  • Dalteparin