Fragmin in Unstable Coronary Artery Disease - FRIC

Description:

Dalteparin versus unfractionated heparin in unstable CAD.

Hypothesis:

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.

Study Design

Study Design:

Patients Screened: Not reported
Patients Enrolled: 1482
NYHA Class: Not reported
Mean Follow Up: 45 days
Mean Patient Age: 25-92 (median 65)
Female: 46%
Mean Ejection Fraction: Not evaluated

Patient Populations:

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.

Exclusions:

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.

Primary Endpoints:

Detah, MI, or recurrent angina.

Secondary Endpoints:

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

Drug/Procedures Used:

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.

Principal Findings:

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%].

Interpretation:

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.

References:

Circulation 1997; 96:61–68

Clinical Topics: Anticoagulation Management

Keywords: Dalteparin, Electrocardiography


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