Last updated: 11/07/2018 00:07:12

OASIS-6 : The safety and efficacy of fondaparinux versus control therapy in patients with ST segment elevation acute myocardial infarction

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GSK study ID
103413
See study documents
Clinicaltrials.gov ID
NCT00064428
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Death or recurrent myocardial infarction

Timeframe: up to day 30

Severe hemorrhage

Timeframe: up to Day 9

Secondary outcomes:

Death or recurrent myocardial infarction

Timeframe: up to Day 9, 90 and 180

Death, recurrent myocardial infarction or refractory ischemia

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

Interventions:
  • Drug: fondaparinux - UFH not indicated
  • Other: Control - UFH not indicated
  • Drug: Fondaparinux - UFH indicated
  • Drug: Control - UFH
    • Enrollment:
    12092
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    The OASIS 6 Trial Group. Effects of Fondaparinux on Mortality and Reinfarction in Patients with Acute ST Segment JAMA. 2006; 295:1519-1530
    Medical condition
    Thromboembolism
    Product
    fondaparinux sodium
    Collaborators
    Sanofi Aventis
    Study date(s)
    August 2003 to February 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    21+ years
    Accepts healthy volunteers
    No
    • Subjects who presented or were admitted to hospital with:
    • a. Signs and symptoms of AMI
    • Age <21 years.
    • Was currently receiving an oral anticoagulant agent with an INR >1.8.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who presented or were admitted to hospital with: a. Signs and symptoms of AMI b. Were able to randomize within 12 hours of symptom onset; and- c. 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
    Exclusion criteria:
    • 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.
    • 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-17-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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