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

Phase 3

Completed

• Conditions: Unstable Angina; Myocardial Infarction; Myocardial Ischemia

• Registration Number: NCT00043784
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2002-08-13
• Study First Submitted QC: 2002-08-14
• Study First Posted: 2002-08-15
• Primary Completion: 2005-02
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-15
• Last Update Posted: 2008-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States