Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Patients experiencing a mild heart attack will receive one of two medications which thin the blood to discern which is superior.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Enoxaparin
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.