NCT00043784

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 13, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

3.5 years

First QC Date

August 13, 2002

Last Update Submit

September 15, 2008

Conditions

Unstable AnginaMyocardial InfarctionMyocardial Ischemia

Keywords

Acute coronary syndromesnon-ST-segment elevation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Interventions

enoxaparinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 07969, United States

Location

Related Publications (7)

  • 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. doi: 10.1001/jama.294.20.2594.

    PMID: 16304073RESULT

  • 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. Epub 2008 Feb 21.

    PMID: 18440330RESULT

  • 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. doi: 10.1007/s11606-007-0498-4. Epub 2008 Jan 15.

    PMID: 18196350RESULT

  • 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. doi: 10.1001/jama.292.1.45.

    PMID: 15238590RESULT

  • 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. doi: 10.1016/j.jacc.2006.05.058. Epub 2006 Sep 12.

    PMID: 17010793RESULT

  • Mahaffey KW, Pieper KS, Lokhnygina Y, Califf RM, Antman EM, Kleiman NS, Goodman SG, White HD, Rao SV, Hochman JS, Cohen M, Col JJ, Roe MT, Ferguson JJ; SYNERGY Investigators. The impact of postrandomization crossover of therapy in acute coronary syndromes care. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):211-9. doi: 10.1161/CIRCOUTCOMES.109.853598. Epub 2011 Feb 8.

    PMID: 21304094DERIVED

  • 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. doi: 10.1016/j.jcin.2008.03.019.

    PMID: 19463332DERIVED

MeSH Terms

Conditions

Angina, UnstableMyocardial InfarctionMyocardial IschemiaAcute Coronary Syndrome

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Angina PectorisHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Doug Green

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2002

First Posted

August 15, 2002

Study Start

August 1, 2001

Primary Completion

February 1, 2005

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

US(1)