ASPIRIN TO PREVENT RECURRENT VENOUS THROMBOEMBOLISM (ASPIRE)
Phase 3
Completed
- Conditions
- Health Condition 1: I824- Acute embolism and thrombosis of deep veins of lower extremityHealth Condition 2: null- first episode of unprovoked proximal DVT or PE
- Registration Number
- CTRI/2007/091/000029
- Lead Sponsor
- ational Health and Medical Research Council NHMRC Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
men and women aged over 18 ;
- first episode of unprovoked proximal DVT or PE
- completion of initial treatment with unfractionated heparin or low-molecular-weight heparin (or effective alternative) and warfarin (recommended treatment duration 6 - 12 months)
Exclusion Criteria
- allergy, intolerance, or contraindication for aspirinclear indication for aspirin, clopidogrel, or a conventional (COX 1/2) NSAID;
-indication for long-term anticoagulant therapy (e.g. prosthetic heart valve);
- life expectancy less than 12 months;
- active bleeding or at high risk of bleeding
- anticipated non-adherence to study medications;
- inability to attend follow up because of geographic inaccessibility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The composite of objectively diagnosed symptomatic VTE or fatal PETimepoint: 5 YEARS
- Secondary Outcome Measures
Name Time Method Symptomatic VTE, myocardial infarction, stroke, all cause mortality and major bleeding (a measure of net clinical benefit). â?¢ Major and minor bleeding. â?¢ The incidence of post-phlebitic syndrome and an assessment of cost-effectiveness of therapy will be incorporated in sub-studies within the trialTimepoint: 5years;The composite of symptomatic VTE, myocardial infarction, stroke, or cardiovascular death (all serious thrombotic vascual events).Timepoint: 5 years