SYNERGY: Open Study of Enoxaparin Versus Unfractionated Heparin in Patients With Acute Coronary Syndromes

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00043784
First received: August 13, 2002
Last updated: September 15, 2008
Last verified: September 2008
  Purpose

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


Condition Intervention Phase
Unstable Angina
Myocardial Infarction
Myocardial Ischemia
Drug: enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-Label, Multicenter Study in Patients Presenting With Acute Coronary Syndromes (ACS)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8000
Study Start Date: August 2001
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

  • 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.
  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: NCT00043784

Locations
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 07969
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Doug Green Sanofi
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00043784     History of Changes
Other Study ID Numbers: ENO_GMA_301
Study First Received: August 13, 2002
Last Updated: September 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Acute coronary syndromes
non-ST-segment elevation

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina, Unstable
Coronary Artery Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Syndrome
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Coronary Disease
Disease
Heart Diseases
Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014