Fragmin in Unstable Coronary Artery Disease - FRIC
Dalteparin versus unfractionated heparin in unstable CAD.
To compare the efficacy and safety of weight-adjusted subcutaneous dalteparin with unfractionated heparin in the acute treatment of unstable angina or non–Q-wave MI and the value of prolonged dalteparin compared with placebo in those initially anticoagulated.
Patients Screened: Not reported
Patients Enrolled: 1482
NYHA Class: Not reported
Mean Follow Up: 45 days
Mean Patient Age: 25-92 (median 65)
Mean Ejection Fraction: Not evaluated
Chest pain in preceding 72 hours and admission ECG with temporary or persistent ST depression ≥1 mV in at least two adjacent leads and/or temporary or persistent T-wave inversion ≥1 mm in two adjacent leads.
New Q waves, left bundle branch block, indication for thrombolytic therapy, pacemaker, known primary myocardial disease, septic endocarditis, pericarditis, aortic valuvular disease of hemodynamic significance, ongoing oral anticoagulation or heparin, DBP >120 mmHg or SBP <90 mmHg, bleeding diathesis or recent surgery, history of cerebrovascular event.
Detah, MI, or recurrent angina.
Death, MI, and recurrence of angina occurring in the acute phase of the study, revascularization by PTCA or ACBG during either phase of study, and ischemia during exercise testing; safety endpoints: major and minor bleeding, thrombocytopenia, and allergic reactions
Phase 1 (open label, days 1–6): Dalteparin 120 IU/kg subcutaneously twice daily or intravenous unfractionated heparin. Phase 2 (double-blind, days 6–45): Dalteparin 7,500 IU subcutaneously once daily or placebo.
There were no significant differences between groups in the 6 day incidence of the primary composite endpoint of death, MI, or recurrent angina [7.6% (heparin) vs. 9.3% (dalteparin), 95% CI 0.84–1.66]. There were also no significant differences in the incidence of death and MI (3.6% vs. 3.9%) or revascularization (5.3% vs. 4.8%). For days 6–45, there were similar incidences of primary composite endpoint (both 12.3%) and revascularization [14.2% (placebo) vs. 14.3%].
Dalteparin was not superior to unfractionated heparin for patients with unstable angina or no-Q wave MI. Prolonged therapy with dalteparin provided no significant additional benefit.
Circulation 1997; 96:61–68
Clinical Topics: Anticoagulation Management
Keywords: Dalteparin, Electrocardiography
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