None listed
Conditions
Brief summary
The ASPIRE is looking at the effectiveness and safety of giving low-dose aspirin to prevent recurrent deep vein thrombosis (DVT) or pulmonary embolism (PE) in patients with a first episode of unprovoked venous thromboembolism (VTE) who have completed initial anticoagulant treatment with heparin and warfarin. Recruitment has now closed, with 822 patients enrolled from centres in Australia, New Zealand, Singapore, India and Argentina. The ASPIRE study addresses a question of major clinical and public health importance with several million patients at risk of recurrent VTE worldwide. If aspirin is found to be beneficial, this safe, inexpensive, and practicable intervention could be very widely applied and prevent thousands of patients from experiencing recurrent venous thromboembolism each year. In Australia alone, a 30% reduction in risk of recurrent VTE could conservatively be expected to prevent 375 to 525 cases of venous thrombosis and save 56-80 lives in the first year.
Interventions
The ASPIRE study is an international multicentre, randomised, double-blind placebo controlled clinical trial designed to examine the efficacy and safety of low dose aspirin (100mg daily) to prevent recurrent deep venous thrombosis (DVT) or pulmonary embolism (PE) in patients with a first episide of unprovoked VTE who have completed initial treatment with heparin and warfarin.
Sponsors
NHMRC Clinical Trials Centre, University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed