Last updated: 11/07/2018 10:22:00

Cost-effectiveness of fondaparinux versus enoxaparin in non-ST-elevation acute coronary syndrome in Canada (OASIS-5) (1)

GSK study ID
116320
Clinicaltrials.gov ID
Not applicable
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: Cost-effectiveness of fondaparinux versus enoxaparin in non-ST-elevation acute coronary syndrome in Canada (OASIS-5) (1)
Trial description: The Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators (OASIS-5) trial (3) showed similar rates of ischemic events at 9 days, but fondaparinux reduced major bleeding and improved mortality and morbidity at 180 days compared to enoxaparin. Based on data from OASIS-5 and other sources, the cost-effectiveness of fondaparinux was established for the management of NSTE-ACS in the United States (2). The cost-effectiveness in the Canadian setting was also of interest.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Days in hospital

Timeframe: 180 days

Selected concomitant medicines

Timeframe: 180 days

Number with one or more selected procedures

Timeframe: 180 days

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fondaparinux
  • Drug: Enoxaparin
  • Enrollment:
    1403
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Ross Terres JA, Lozano-Ortega G, Kendall R, Sculpher MJ. Cost-effectiveness of fondaparinux versus enoxaparin in non-ST-elevation acute coronary syndrome in Canada (OASIS-5). BMC Cardiovasc Disord. 2015;15:180.
    Medical condition
    acute coronary syndrome
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to February 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    21+ years
    Accepts healthy volunteers
    none
    • All patients enrolled in Canadian centers participating in the OASIS- 5 trial

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English

    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
    2010-12-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website