Trials > ASPIRE Aspirin to prevent recurrent venous thromboembolism
(ASPIRE)
Project manager–trial coordinator: Rebecca Mister
Eligibility
a previous first episode of unprovoked
deep-vein thrombosis in a major vein or pulmonary embolism
previous initial treatment with heparin
(or effective alternative) and warfarin (for 3 to 12 months)
Each year, an estimated 20 000 Australians
develop deep-vein thrombosis (a blood clot) or pulmonary embolism
(a clot that travels to the lungs) for the first time. A third have
no known cause. The average age for a first episode is 65 years.
Each year, as many as 5000 in Australia have a further episode,
and several hundred die of fatal pulmonary embolism.
There
is a great need to identify a simple, safe and effective way to prevent
further thrombosis where the cause of the thrombosis is not known.
This Australian designed and initiated study is addressing a scientific
question of major public health importance and has the potential to
prevent thousands of patients worldwide from experiencing recurrent
venous thromboembolism.
The
ASPIRE trial will test the use of low-dose aspirin to prevent further
clotting.
The trial is multicentre, randomised, double-blind,
placebo-controlled trial examining the efficacy and safety of low-dose
aspirin after treatment with oral anticoagulant drugs (heparin or
an effective alternative and warfarin) in preventing further
venous thrombosis and pulmonary embolism.
Study drug
•
100 mg
aspirin (acetylsalicylic acid)
Main
outcome measure
•
objectively
diagnosed symptomatic venous thromboembolism or fatal pulmonary embolism
Accrual: 3000
patients followed up for 2 to 4 years
Funding: NHMRC, Bayer, Australian Society
for Thrombosis and Haemostasis, NSW Department of Health
The pilot phase of this study ran from May 2003 until July 2004. The
main study is currently under way.