Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)

Phase 4

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT00077818
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to determine the efficacy and safety of enoxaparin compared to unfractionated heparin (UFH) for patients diagnosed with Acute Coronary Syndrome (ACS) in the emergency department (ED). Efficacy is assessed by using a composite score consisting of 30-day all-cause mortality, non-fatal myocardial infarction (MI) and recurrent angina requiring revascularization.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2004-02-12
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Primary Completion: 2005-02
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-14
• Last Update Posted: 2009-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess a composite score that considers the occurrence of all-cause mortality, non-fatal MI, or recurrent angina requiring the need for revascularization	up to 30 days (± 2 days) following randomization

Secondary Outcome Measures

Name	Time	Method
Incidence of major hemorrhage	during the index hospitalization
Incidence of minor hemorrhage	during the index hospitalization
Combined incidence of 30-day all-cause mortality and nonfatal MI	at 30 days
The incidence of 30-day all-cause mortality by itself	At 30 days
Total health care utilization	from baseline (initial hospitalization) through the Day 30 follow-up visit.