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)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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
Inclusion and exclusion criteria
Inclusion criteria:
- All patients enrolled in Canadian centers participating in the OASIS- 5 trial
Trial location(s)
No location data available.
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
Finalized
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
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