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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Enoxaparin sodium
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Secondary Outcome Measures

    Incidence of major hemorrhage
    Incidence of minor hemorrhage
    Combined incidence of 30-day all-cause mortality and nonfatal MI
    The incidence of 30-day all-cause mortality by itself
    Total health care utilization

    Full Information

    First Posted
    February 12, 2004
    Last Updated
    October 14, 2009
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00077818
    Brief Title
    Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    February 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Enoxaparin sodium
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Incidence of major hemorrhage
    Time Frame
    during the index hospitalization
    Title
    Incidence of minor hemorrhage
    Time Frame
    during the index hospitalization
    Title
    Combined incidence of 30-day all-cause mortality and nonfatal MI
    Time Frame
    at 30 days
    Title
    The incidence of 30-day all-cause mortality by itself
    Time Frame
    At 30 days
    Title
    Total health care utilization
    Time Frame
    from baseline (initial hospitalization) through the Day 30 follow-up visit.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luc Sagnard
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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