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ThromboembolismPhase 3NCT00064428

OASIS-6 : The Safety and Efficacy of Fondaparinux Versus Control Therapy in Patients With ST Segment Elevation Acute Myocardial Infarction

A Phase 3 study testing fondaparinux - UFH not indicated and Fondaparinux - UFH indicated in people with Thromboembolism, run by GlaxoSmithKline.

Completed

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

Official record
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Trial summary

This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Thromboembolism
What is being tested?
fondaparinux - UFH not indicated and Fondaparinux - UFH indicated
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12,092 participants
Where
No sites listed yet
Study dates
Aug 2003to Feb 2006
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who presented or were admitted to hospital with:
  • Signs and symptoms of AMI
  • Were able to randomize within 12 hours of symptom onset; and-
  • Had definite ECG changes indicating STEMI: persistent ST-elevation (≥0.2mV in two contiguous precordial leads, or ≥0.1mV in at least two limb leads), or new left bundle branch block, or ECG changes indicating true posterior MI.
  • Written informed consent
  • Able to be randomized within 24 hours of symptom onset

Who cannot join

  • Age <21 years.
  • Was currently receiving an oral anticoagulant agent with an INR >1.8.
  • Had any contraindication to anticoagulation therapy such as high risk of bleeding or active bleeding.
  • Had hemorrhagic stroke within the last 12 months.
  • Had an indication for anticoagulation other than ACS.
  • Pregnant women or women of child-bearing potential who were not using an effective method of contraception.
Show all 15Show fewer
  • Had a co-morbid condition with a life-expectancy <6 months.
  • Previous enrollment in one of the fondaparinux ACS trials.
  • Participation in another pharmacotherapeutic study within the prior 30 days or was currently receiving an experimental pharmacological agent.
  • Had a known allergy to heparin or fondaparinux.
  • Had severe renal insufficiency (i.e. serum creatinine ≥3mg/dL or ≥265μmol/L).
  • Had >5000IU UFH administered prior to randomization.
  • Had LMWH administered prior to randomization.
  • Subject had pre-randomization revascularization (PCI) for the index event.
  • Subject had pre-randomization rescue PCI.

About this study

Official title: An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction.

This is a randomized, double blindcontrolled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI (ST segment myocardial infarction) randomized within 24 hours of the onset of symptoms.

Read the detailed description

This is a randomized, double blind, controlled, parallel group, multi-center, multinational study of fondaparinux vs. control in patients with STEMI randomized within 24 hours of the onset of symptoms. Patients with confirmed STEMI were assigned into one of the following strata, based on local preference:

Stratum 1: No indication for UFH; it is generally accepted that patients receiving streptokinase or those not receiving a thrombolytic agent were assigned to this stratum.

Stratum 2: Indication for UFH; it is generally accepted that patients receiving a fibrin-specific agent (such as alteplase, reteplase or tenecteplase) or those undergoing primary PCI were assigned to this stratum.

Patients who were ineligible for fibrinolysis (e.g. because of late presentation or absolute contra-indication for reperfusion therapy) may fall into either stratum 1 or stratum 2 at investigator's discretion. Following allocation to one of the strata, patients were randomized to fondaparinux or control treatment. Control treatment was dependent on whether the patient was assigned to stratum 1 or stratum 2:

Stratum 1: fondaparinux sc* versus fondaparinux-placebo sc for 8 days or until hospital discharge, whichever was earlier.

Stratum 2: fondaparinux sc* for 8 days or until hospital discharge, whichever was earlier and UFH-placebo for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) versus UFH for 24 to 48 hrs (or single bolus injection immediately prior to procedure in case of primary PCI) and fondaparinux-placebo for 8 days or until hospital discharge, whichever was earlier.

(*First dose intravenous bolus) Patients were followed up for 6 months

Conditions
Thromboembolism
Being tested
fondaparinux - UFH not indicated, Control - UFH not indicated, Fondaparinux - UFH indicated, Control - UFH
Keywords
ST-segment elevation myocardial infarction, fondaparinux, Acute Myocardial Infarction, acute coronary syndrome
Medical subject headings
Thromboembolism, ST Elevation Myocardial Infarction, Acute Coronary Syndrome

What participants receive

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

  • fondaparinux - UFH not indicatedDrug

    2.5mg od, sc (1st dose IV) x 8 days or discharge

  • Control - UFH not indicatedOther

    Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

  • Fondaparinux - UFH indicatedDrug

    2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus x 24-48 hr infusion

  • Control - UFHDrug

    UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge

Study groups in NCT00064428
Study groupRoleWhat they receive
Fondaparinux - UFH not indicatedExperimentalSubjects with no indication for UFH therapy: 2.5mg od, sc, (1st dose IV) x 8 days or discharge
Receives: Drug: fondaparinux - UFH not indicated
Control - UFH not indicatedPlacebo comparatorSubjects with no indication for UFH therapy: Fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Receives: Other: Control - UFH not indicated
Fondaparinux - UFH indicatedExperimentalSubjects indicated for UFH: 2.5mg od, sc (1st dose IV) x 8 days or discharge + UFH-placebo IV bolus + 24-48 hr infusion
Receives: Drug: Fondaparinux - UFH indicated
Control - unfractionated heparinActive comparatorSubjects indicated for UFH: UFH IV bolus +12 IU/kg/hr infusion x 24-48 hr + fondaparinux-placebo od, sc (1st dose IV) x 8 days or discharge
Receives: Drug: Control - UFH

What is being measured

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

  1. Death or recurrent myocardial infarction

    the first occurrence of any component of death (all-cause mortality) or recurrent myocardial infarction

    Measured: up to day 30

  2. Severe hemorrhage

    Severe hemorrhage (modified TIMI criteria)

    Measured: up to Day 9

Secondary outcomes (2)

  1. Death or recurrent myocardial infarction

    The first occurrence of any component of the composite of death (all-cause mortality) or recurrent myocardial infarction

    Measured: up to Day 9, 90 and 180

  2. Death, recurrent myocardial infarction or refractory ischemia

    The first occurrence of any component of the composite of death (all-cause mortality), recurrent myocardial infarction or refractory ischemia

    Measured: up to Day 9, 30, 90 and 180

Timeline

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

  1. First posted17 Oct 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12,092 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064428
Sponsor's protocol ID
103413
Status last verified
Sep 2016
First submitted
8 Jul 2003
Last updated
23 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA; OASIS-6 Trial Group. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006 Apr 5;295(13):1519-30. doi: 10.1001/jama.295.13.joc60038. Epub 2006 Mar 14.

    PubMed 16537725

  • Diaz R, Goyal A, Mehta SR, Afzal R, Xavier D, Pais P, Chrolavicius S, Zhu J, Kazmi K, Liu L, Budaj A, Zubaid M, Avezum A, Ruda M, Yusuf S. Glucose-insulin-potassium therapy in patients with ST-segment elevation myocardial infarction. JAMA. 2007 Nov 28;298(20):2399-405. doi: 10.1001/jama.298.20.2399.

    PubMed 18042917

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fondaparinux - UFH not indicated and Fondaparinux - UFH indicated in people with Thromboembolism, run by GlaxoSmithKline.

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 15 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Death or recurrent myocardial infarction (time frame: up to day 30). 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 NCT00064428, which also lists 2 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 23 Sep 2016.

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Clinical Trial NCT00064428 | AzTrials