ASPIRE
Phase 3
Completed
- Conditions
- Venous thromboembolismCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12605000004662
- Lead Sponsor
- HMRC Clinical Trials Centre, University of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 822
Inclusion Criteria
First episode of unprovoked DVT or PE-completion of initial treatment with unfractionated heparin or low-molecular-weight heparin (or effective alternative) and warfarin (recommended treatment duration 6-24 months)
Exclusion Criteria
Allergy, intolerance or contraindication for aspirin-Clear indication for aspirin, clopidogrel or a conventional (COX 1/2) NSAID.-Indication for long-term anticoagulant therapy (eg prosthetic heart valve)-Life expectancy of less than 12 months-active bleeding or at high risk of bleeding-anticipated non-adherance to study medications-inability to attend follow-up because of geographical inaccessibility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the composite of objectively diagnosed symptomatic VTE or fatal PE[At the end of the study]
- Secondary Outcome Measures
Name Time Method A) The composite of symptomatic VTE, myocardial infarction, stroke, or cardiovascular death (all serious thrombotic vascual events).[At the end of the study];B) Symptomatic VTE , myocardial infarction, stroke, all cause mortality and major bleeding (a measure of net clinical benefit).[At the end of the study]