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

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ClinicalTrials.gov Identifier: NCT00077818
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : October 15, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Enoxaparin sodium Phase 4

Expanded Access : Sanofi has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2002
Actual Primary Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Primary Outcome Measures :
  1. To assess a composite score that considers the occurrence of all-cause mortality, non-fatal MI, or recurrent angina requiring the need for revascularization [ Time Frame: up to 30 days (± 2 days) following randomization ]

Secondary Outcome Measures :
  1. Incidence of major hemorrhage [ Time Frame: during the index hospitalization ]
  2. Incidence of minor hemorrhage [ Time Frame: during the index hospitalization ]
  3. Combined incidence of 30-day all-cause mortality and nonfatal MI [ Time Frame: at 30 days ]
  4. The incidence of 30-day all-cause mortality by itself [ Time Frame: At 30 days ]
  5. Total health care utilization [ Time Frame: from baseline (initial hospitalization) through the Day 30 follow-up visit. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077818

Sponsors and Collaborators
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Study Director: Luc Sagnard Sanofi
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00077818    
Other Study ID Numbers: XRP4563B_4001
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Pathologic Processes
Disease Attributes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Enoxaparin sodium
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action