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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00077818
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 12, 2004
First Posted Date  ICMJE February 16, 2004
Last Update Posted Date October 15, 2009
Study Start Date  ICMJE June 2002
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00077818 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • Incidence of major hemorrhage [ Time Frame: during the index hospitalization ]
  • Incidence of minor hemorrhage [ Time Frame: during the index hospitalization ]
  • Combined incidence of 30-day all-cause mortality and nonfatal MI [ Time Frame: at 30 days ]
  • The incidence of 30-day all-cause mortality by itself [ Time Frame: At 30 days ]
  • Total health care utilization [ Time Frame: from baseline (initial hospitalization) through the Day 30 follow-up visit. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE Drug: Enoxaparin sodium
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00077818
Other Study ID Numbers  ICMJE XRP4563B_4001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Luc Sagnard Sanofi
PRS Account Sanofi
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP