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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043784
• Other study ID #: ENO_GMA_301
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2002
• Last updated: September 15, 2008
• Start date: August 2001

Study information

• Verified date: September 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Coronary Artery Disease
• Myocardial Infarction
• Myocardial Ischemia
• Unstable Angina

Intervention

Drug:
• enoxaparin

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (5)

Chew DP, Mahaffey KW, White HD, Huang Z, Hoekstra JW, Ferguson JJ, Califf RM, Aylward PE. Coronary artery bypass surgery in patients with acute coronary syndromes is difficult to predict. Am Heart J. 2008 May;155(5):841-7. doi: 10.1016/j.ahj.2007.12.002. — View Citation

Cohen M, Mahaffey KW, Pieper K, Pollack CV Jr, Antman EM, Hoekstra J, Goodman SG, Langer A, Col JJ, White HD, Califf RM, Ferguson JJ; SYNERGY Trial Investigators. A subgroup analysis of the impact of prerandomization antithrombin therapy on outcomes in th — View Citation

Ferguson JJ, Califf RM, Antman EM, Cohen M, Grines CL, Goodman S, Kereiakes DJ, Langer A, Mahaffey KW, Nessel CC, Armstrong PW, Avezum A, Aylward P, Becker RC, Biasucci L, Borzak S, Col J, Frey MJ, Fry E, Gulba DC, Guneri S, Gurfinkel E, Harrington R, Hoc — View Citation

Mahaffey KW, Cohen M, Garg J, Antman E, Kleiman NS, Goodman SG, Berdan LG, Reist CJ, Langer A, White HD, Aylward PE, Col JJ, Ferguson JJ 3rd, Califf RM; SYNERGY Trial Investigators. High-risk patients with acute coronary syndromes treated with low-molecul — View Citation

Mahaffey KW, Yang Q, Pieper KS, Antman EM, White HD, Goodman SG, Cohen M, Kleiman NS, Langer A, Aylward PE, Col JJ, Reist C, Ferguson JJ, Califf RM; SYNERGY Trial Investigators. Prediction of one-year survival in high-risk patients with acute coronary syn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To measure the incidence of major bleeding.		during the index hospitalization	No
Secondary	Incidence of minor and all bleeding		during the index hospitalization	No
Secondary	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	No
Secondary	To evaluate the incidence of all-cause mortality		within 6 months and 1 year after randomization	No
Secondary	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	No