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

A Prospective, Open-label, Randomized, Parallel-group Investigation to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Enoxaparin sodium

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

• Rest angina lasting at least 10 minutes that is highly suggestive of myocardial ischemia and is not explained by trauma or obvious abnormalities on chest x-ray, occurring within 24 hours of randomization;
• TIMI risk score greater than or equal to 4 (a qualitative test for CK-MB or Troponin may be utilized for screening purposes; however, a quantitative test must still be performed.)

EXCLUSION CRITERIA

• Increased bleeding risk as defined by any of the following:

  • Ischemic stroke within the last year
  • Any previous hemorrhagic stroke, intracranial tumor, or intracranial aneurysm
  • Recent (<1 month) trauma or major surgery (including bypass surgery)
  • Active bleeding (other than minor skin abrasions)

• Impaired hemostasis including any one of the following:

  • Known International Normalized Ratio (INR) >1.5
  • Past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders)
  • Known or history of thrombocytopenia (platelet count <100,000/mL)
  • History of thrombocytopenia with glycoprotein IIb/IIIa inhibitor therapy, heparin, or enoxaparin

• Angina from a secondary cause such as:

  • severe, uncontrolled hypertension (systolic blood pressure >180 mm Hg despite treatment)
  • anemia
  • valvular disease
  • congenital heart disease
  • hypertrophic cardiomyopathy
  • restrictive or constrictive cardiomyopathy
  • thyrotoxicosis.
• Bundle branch block not known to be old in the context of angina.
• Undergone a percutaneous coronary intervention (PCI) within the past 24 hours.
• A known allergy to heparin, low molecular weight heparin, pork or pork products.
• Any contraindications to treatment with UFH or LMWH.
• A recent (<48 hours) or planned spinal/epidural anesthesia or puncture.
• Thrombolytic therapy within the preceding 24 hours.
• Any other clinically relevant serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min], rendering implementation of the protocol or interpretation of the study results difficult.
• Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or has previously enrolled in this trial.
• Inability to comply with the protocol (e.g., has uncooperative attitude, inability to return for follow-up visits).
• Inability to understand the nature, scope, and possible consequences of the study or is otherwise unable to provide informed consent.
• A prosthetic heart valve

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Luc Sagnard, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: February 12, 2004
• First Submitted That Met QC Criteria: February 13, 2004
• First Posted (Estimate): February 16, 2004

Study Record Updates

• Last Update Posted (Estimate): October 15, 2009
• Last Update Submitted That Met QC Criteria: October 14, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Disease; Syndrome; Emergencies; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: XRP4563B_4001