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

September 15, 2008 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

8000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 07969
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 30 days after randomization
To measure the incidence of major bleeding.
Time Frame: during the index hospitalization
during the index hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of minor and all bleeding
Time Frame: during the index hospitalization
during the index hospitalization
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
within 14 and 30 days after randomization
To evaluate the incidence of all-cause mortality
Time Frame: within 6 months and 1 year after randomization
within 6 months and 1 year after randomization
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
within 14 days and all-cause mortality or nonfatal MI within 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Doug Green, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

August 13, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Estimate)

September 16, 2008

Last Update Submitted That Met QC Criteria

September 15, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENO_GMA_301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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