Aspirin for the Prevention of Recurrent Venous Thromboembolism
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ClinicalTrials.gov Identifier: NCT00222677
Recruitment Status : Unknown
Verified August 2011 by Cecilia Becattini, University Of Perugia. Recruitment status was: Active, not recruiting
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
recurrence of VTE and/or VTE related death [ Time Frame: at least 24 months per patient ]
Secondary Outcome Measures :
recurrent VTE+ death; cardiovascular events, bleeding events, critical ischemia of the lower limbs, mesenteric infarction, all cause mortality and newly diagnosed cancer [ Time Frame: at least 24 months per patient ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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)
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 (gastrointestinal bleeding within the past 12 months; endoscopic diagnosis of peptic ulcer disease or ulcerative esophagitis within the past 6 months unless there is documented endoscopic evidence of healing; intracranial bleeding within the past year; known bleeding diathesis)
anticipated non-adherence to study medications
inability to attend follow up because of geographic inaccessibility