AzTrials
AzTrials

Unstable AnginaPhase 3NCT00043784

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

A Phase 3 study testing enoxaparin in people with Unstable Angina and Myocardial Infarction, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
enoxaparin
How many people
8,000 participants
Where
1 siteUnited States
Study dates
Aug 2001to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Clinical Research Institute

    Durham, North Carolina, 07969

Other trials in United States

About this study

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

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

Being tested
enoxaparin
Keywords
Acute coronary syndromes, non-ST-segment elevation
Medical subject headings
Angina, Unstable, Myocardial Infarction, Myocardial Ischemia, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure the composite endpoint of all-cause mortality or the first clinical events committee (CEC)-adjudicated nonfatal myocardial infarction

    Measured: within 30 days after randomization

  2. To measure the incidence of major bleeding.

    Measured: during the index hospitalization

Secondary outcomes (4)

  1. Incidence of minor and all bleeding

    Measured: during the index hospitalization

  2. 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

    Measured: within 14 and 30 days after randomization

  3. To evaluate the incidence of all-cause mortality

    Measured: within 6 months and 1 year after randomization

  4. To evaluate the combined incidence of all-cause mortality or CEC-adjudicated nonfatal MI

    Measured: within 14 days and all-cause mortality or nonfatal MI within 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2002 (estimated)
  2. Study startAug 2001
  3. Primary completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00043784
Sponsor's protocol ID
ENO_GMA_301
Status last verified
Sep 2008
First submitted
13 Aug 2002
Last updated
16 Sep 2008
Results posted
No

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. doi: 10.1001/jama.294.20.2594.

    PubMed 16304073

  • 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.

    PubMed 18440330

  • 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.

    PubMed 18196350

  • 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.

    PubMed 15238590

  • 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.

    PubMed 17010793

  • 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.

    PubMed 21304094

  • 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.

    PubMed 19463332

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing enoxaparin in people with Unstable Angina and Myocardial Infarction, run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00043784, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in