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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00043784

Collaborator

(none)

8,000

Enrollment

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Unstable Angina Myocardial Infarction Myocardial Ischemia	Drug: enoxaparin	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Open-Label, Multicenter Study in Patients Presenting With Acute Coronary Syndromes (ACS)

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Feb 1, 2005

Outcome Measures

Primary Outcome Measures

To measure the composite endpoint of all-cause mortality or the first clinical events committee (CEC)-adjudicated nonfatal myocardial infarction [within 30 days after randomization]
To measure the incidence of major bleeding. [during the index hospitalization]

Secondary Outcome Measures

Incidence of minor and all bleeding [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 [within 14 and 30 days after randomization]
To evaluate the incidence of all-cause mortality [within 6 months and 1 year after randomization]
To evaluate the combined incidence of all-cause mortality or CEC-adjudicated nonfatal MI [within 14 days and all-cause mortality or nonfatal MI within 6 months after randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.