NHMRC Clinical Trials Centre: ASPIRE

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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 24 months)

Each year, an estimated 30 000 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: 2000 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.

For futher information please contact aspire@ctc.usyd.edu.au