INSPIRE (International trials of aspirin to prevent recurrent venous thromboembolism)
Phase 3
Completed
- Conditions
- Venous thromboembolismCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12611000684921
- Lead Sponsor
- niversity of Sydney (ASPIRE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2000
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 end of study (4 years treatment duration)]
- Secondary Outcome Measures
Name Time Method A) The composite of symptomatic VTE, myocardial infarction, stroke, or cardiovascular death (all serious thrombotic vascular events).[At end of study (4 years treatment duration)];B) Symptomatic VTE , myocardial infarction, stroke, all cause mortality and major bleeding (a measure of net clinical benefit).[At end of study (4 years treatment duration)];C) Major and minor bleeding<br>Major bleeding defined as clinically overt bleeding <br>Minor bleeding defined as all other bleeding episodes not meeting the definition of major bleeding, but which lead to discontinuation of study medication[At end of study (4 years treatment duration)]