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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00077818
First received: February 12, 2004
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Drug: Enoxaparin sodium
Phase 4

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of major hemorrhage [ Time Frame: during the index hospitalization ] [ Designated as safety issue: No ]
  • Incidence of minor hemorrhage [ Time Frame: during the index hospitalization ] [ Designated as safety issue: No ]
  • Combined incidence of 30-day all-cause mortality and nonfatal MI [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
  • The incidence of 30-day all-cause mortality by itself [ Time Frame: At 30 days ] [ Designated as safety issue: No ]
  • Total health care utilization [ Time Frame: from baseline (initial hospitalization) through the Day 30 follow-up visit. ] [ Designated as safety issue: No ]

Study Start Date: June 2002
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077818

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Luc Sagnard Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00077818     History of Changes
Other Study ID Numbers: XRP4563B_4001
Study First Received: February 12, 2004
Last Updated: October 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014