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Fraxiparin Versus Unfractionated Heparin in the Treatment of Unstable Angina - FRAXIS
Description:
Fraxiparin vs. heparin in unstable angina or non-Q-wave MI.
Hypothesis:
To compare a low molecular weight heparin (Fraxiparin) with unfractionated heparin in unstable angina or non-Q-wave myocardial infarction.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 3,498
Primary Endpoints:
Cardiovascular death, MI, refractory angina, or recurrent angina within 2 weeks
Secondary Endpoints:
Cardiovascular death, MI, refractory angina, or recurrent angina at 6 days, 4 weeks, and 6 months.
Drug/Procedures Used:
Fraxiparin (6 days), Fraxiparin (14 days) or unfractionated heparin (6 days).
Principal Findings:
The data collected during the evaluation period of 6 days to 3 months showed no significant differences in the event rate for the three groups. There was also no significant difference in the rate at which intervention was needed in the three groups. However, there was a significant excess of bleeding when treatment with Fraxiparin was prolonged, and the differences that were noted at 2 weeks were maintained at 3 months.
Interpretation:
These data suggest that there may be heterogeneity in activity among the low molecular weight heparins; studies of enoxaparin have been encouraging in this area.
References:
1. Presented at the XXth Congress of the European Society of Cardiology, Vienna, 1998
Keywords: Myocardial Infarction, Enoxaparin, Heparin, Low-Molecular-Weight, Nadroparin
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