Aspirin after six months or one year of oral anticoagulants for the prevention of recurrent venous thromboembolism and cardiovascular events in patients with idiopathic venous thromboembolism. The WARFASA Study. - The WARFASA Study

• Conditions: Venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism.

• Registration Number: EUCTR2004-004260-71-AT
• Lead Sponsor: Medizinische Universität Wien Univ.Klinik f.Innere Medizin I/Hämatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-08
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1378

Inclusion Criteria

Patients will be eligible for inclusion in the study if they meet the following 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with any of the following will be excluded:

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism and cardiovascular events when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism ;Secondary Objective: ;Primary end point(s): Incidence of a combined endpoint of cardiovascular events and recurrence of VTE, defined as the sum of confirmed recurrent symptomatic venous thromboembolism, fatal pulmonary embolism, non-fatal myocardial infarction, non-fatal stroke, cardiovascular death and sudden otherwise unexplained death.