Aspirin for the Prevention of Recurrent Venous Thromboembolism (NCT00222677) | Clinical Trial Compass
UnknownPhase 2/3
Aspirin for the Prevention of Recurrent Venous Thromboembolism
Austria, Italy70 participantsStarted 2004-05
Plain-language summary
To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* first episode of symptomatic, objectively confirmed idiopathic proximal deep vein thrombosis and/or pulmonary embolism;
* initial treatment with unfractionated heparin or low-molecular-weight heparin (or effective alternative) followed by a vitamin K antagonist (target INR 2.0-3.0). All patients will receive 6 or 12 months of oral anticoagulant treatment. Patients initially treated with thrombolytic therapy who received warfarin therapy are eligible for inclusion.
Exclusion Criteria:
* permanent risk factors for venous thromboembolism: patients known to have antiphospholipid antibodies or lupus anticoagulant (based on local laboratory criteria) or to have homozygous factor V Leiden or homozygous prothrombin G21210A or heterozygous factor V Leiden plus heterozygous prothrombin G21210A or antithrombin III deficiency; patients with active malignancy
* temporary risk factors for venous thromboembolism
* any recurrence of venous thromboembolism or bleeding episode during the established 6-month period of oral anticoagulant treatment
* allergy or intolerance of aspirin
* clear indication for aspirin or other anti-platelet therapy (e.g. clopidogrel, ticlopidine)
* clear indication for long-term anticoagulant therapy (e.g. recurrent idiopathic venous thromboembolism, prosthetic heart valve)
* treatment with non-selective COX-1/2 non-steroidal anti-inflammatory drugs
* life expectancy less than 6 months
* active bleeding or at high risk of bleeding (gastrointe…