Status:
UNKNOWN
Aspirin for the Prevention of Recurrent Venous Thromboembolism
Lead Sponsor:
University Of Perugia
Conditions:
Venous Thromboembolism
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 an...
Detailed Description
Background Venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism, is a common disease with an annual incidence of 0.5-1.6 per 1000 in the general population.1-4 Standard ...
Eligibility Criteria
Inclusion
- 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
- 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 (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
- failure to provide informed consent
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00222677
Start Date
May 1 2004
Last Update
August 23 2011
Active Locations (15)
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1
Department of Internal Medicine - University of Vienna
Vienna, Austria, A 1090
2
Unità di Aterosclerosi e Trombosi -Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy, 71013
3
Divisione di Ematologia, Dipartimento di Medicina Interna - Università di Milano-Bicocca
Monza, Milano, Italy
4
Angiologia - Osp. Garibaldi - Piazza S. Maria del Gesù, 7
Catania, Italy, 95123