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SYNERGY: Open Study of Enoxaparin Versus Unfractionated Heparin in Patients With Acute Coronary Syndromes
This study has been completed.
Study NCT00043784   Information provided by Sanofi-Aventis
First Received: August 13, 2002   Last Updated: September 15, 2008   History of Changes

August 13, 2002
September 15, 2008
August 2001
February 2005   (final data collection date for primary outcome measure)
  • To measure the composite endpoint of all-cause mortality or the first clinical events committee (CEC)-adjudicated nonfatal myocardial infarction [ Time Frame: within 30 days after randomization ] [ Designated as safety issue: No ]
  • To measure the incidence of major bleeding. [ Time Frame: during the index hospitalization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00043784 on ClinicalTrials.gov Archive Site
  • Incidence of minor and all bleeding [ Time Frame: during the index hospitalization ] [ Designated as safety issue: No ]
  • To evaluate the combined and individual incidence of all-cause mortality, clinical events committee (CEC)-adjudicated nonfatal MI, stroke, or recurrent ischemia that required revascularization [ Time Frame: within 14 and 30 days after randomization ] [ Designated as safety issue: No ]
  • To evaluate the incidence of all-cause mortality [ Time Frame: within 6 months and 1 year after randomization ] [ Designated as safety issue: No ]
  • To evaluate the combined incidence of all-cause mortality or CEC-adjudicated nonfatal MI [ Time Frame: within 14 days and all-cause mortality or nonfatal MI within 6 months after randomization ] [ Designated as safety issue: No ]
Same as current
 
SYNERGY: Open Study of Enoxaparin Versus Unfractionated Heparin in Patients With Acute Coronary Syndromes
A Prospective, Randomized, Open-Label, Multicenter Study in Patients Presenting With Acute Coronary Syndromes (ACS)

Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Unstable Angina
  • Myocardial Infarction
  • Myocardial Ischemia
Drug: enoxaparin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
8000
 
February 2005   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Male or nonpregnant female greater than or equal to 18 years old
  • Ischemic pain originating or persisting at rest, or its clinical equivalent, lasting greater than or equal to 10 minutes and occurring within the 24 hours before enrollment
  • At least 2 of the following:

    • ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (greater than or equal to 1 mm), or transient (<30 minutes) ST-segment elevation greater than or equal to 0.1 mV (greater than or equal to 1 mm) in at least 2 contiguous leads
    • Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated troponin I or T greater than the established criteria at each site OR creatine kinase CK-MB level greater than the site's upper limit of normal
    • Age greater than or equal to 60 years

Exclusion Criteria:

  • Known or suspected pregnancy
  • Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); active bleeding
  • Impaired hemostasis: 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), thrombocytopenia (platelet count <100,000/mL), or history of thrombocytopenia with GP 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
  • PCI within the past 24 hours, not including coronary angiography only
  • Allergy to pork or pork products
  • Contraindications to UFH or LMWH
  • Recent (<48 hours) or planned spinal/epidural anesthesia or puncture
  • Thrombolytic therapy within the preceding 24 hours
  • Other serious diseases, including severe liver disease or renal failure [creatinine clearance <30 mL/min
  • Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrollment in this trial
  • Inability to give informed consent or high likelihood of being unavailable for follow-up
  • Not a candidate for intervention, (angiography or PCI)
  • Treatment with a direct thrombin inhibitor or a low molecular weight heparin other than enoxaparin in the 7 days preceding enrollment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043784
Medical Affairs Study Director, sanofi-aventis
ENO_GMA_301
Sanofi-Aventis
 
Study Director: Doug Green Sanofi-Aventis
Sanofi-Aventis
September 2008

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