SYNERGY: Open Study of Enoxaparin Versus Unfractionated Heparin in Patients With Acute Coronary Syndromes - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00043784

Purpose

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

Condition	Intervention	Phase
Unstable Angina Myocardial Infarction Myocardial Ischemia	Drug: enoxaparin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Open-Label, Multicenter Study in Patients Presenting With Acute Coronary Syndromes (ACS)

Resource links provided by NLM:

MedlinePlus related topics: Angina Blood Thinners Heart Attack

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To measure the incidence of major bleeding. [ Time Frame: during the index hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of minor and all bleeding [ Time Frame: during the index hospitalization ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To evaluate the incidence of all-cause mortality [ Time Frame: within 6 months and 1 year after randomization ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	8000
Study Start Date:	August 2001
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043784

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Doug Green

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Publications:

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-molecular-weight or unfractionated heparin: outcomes at 6 months and 1 year in the SYNERGY trial. JAMA. 2005 Nov 23;294(20):2594-600.

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. Epub 2008 Feb 21.

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 syndromes: results from the SYNERGY trial. J Gen Intern Med. 2008 Mar;23(3):310-6. Epub 2008 Jan 15.

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, Hochman JS, Kleiman NS, Leon MB, Lopez-Sendon JL, Pepine CJ, Ruzyllo W, Steinhubl SR, Teirstein PS, Toro-Figueroa L, White H; SYNERGY Trial Investigators. Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA. 2004 Jul 7;292(1):45-54.

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 the SYNERGY trial: enoxaparin versus unfractionated heparin in non-ST-segment elevation acute coronary syndromes. J Am Coll Cardiol. 2006 Oct 3;48(7):1346-54. Epub 2006 Sep 12.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Chan MY, Mahaffey KW, Sun LJ, Pieper KS, White HD, Aylward PE, Ferguson JJ, Califf RM, Roe MT. Prevalence, predictors, and impact of conservative medical management for patients with non-ST-segment elevation acute coronary syndromes who have angiographically documented significant coronary disease. JACC Cardiovasc Interv. 2008 Aug;1(4):369-78.

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	ENO_GMA_301
Study First Received:	August 13, 2002
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00043784 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Acute coronary syndromes
non-ST-segment elevation

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hematologic Agents
Angina Pectoris
Pain
Fibrinolytic Agents
Signs and Symptoms
Necrosis
Fibrin Modulating Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Cardiovascular Diseases

Myocardial Infarction
Heart Diseases
Disease
Anticoagulants
Vascular Diseases
Cardiovascular Agents
Ischemia
Pharmacologic Actions
Chest Pain
Enoxaparin
Acute Coronary Syndrome
Infarction
Angina, Unstable

ClinicalTrials.gov processed this record on November 09, 2009