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
First Posted : September 22, 2005
Last Update Posted : August 23, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolism Atherosclerosis | Drug: aspirin | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Aspirin After Six Months or One Year of Oral Anticoagulants for the Prevention of Recurrent Venous Thromboembolism in Patients With Idiopathic Venous Thromboembolism. The WARFASA Study. |
Study Start Date : | May 2004 |
Estimated Primary Completion Date : | January 2012 |
- Drug: aspirin
100 mg daily
- recurrence of VTE and/or VTE related death [ Time Frame: at least 24 months per patient ]
- 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: | All |
Accepts Healthy Volunteers: | No |
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 (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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222677
Austria | |
Department of Internal Medicine - University of Vienna | |
Wien, Austria, A 1090 | |
Italy | |
Unità di Aterosclerosi e Trombosi -Casa Sollievo della Sofferenza | |
San Giovanni Rotondo, FG, Italy, 71013 | |
Divisione di Ematologia, Dipartimento di Medicina Interna - Università di Milano-Bicocca | |
Monza, Milano, Italy | |
Angiologia - Osp. Garibaldi - Piazza S. Maria del Gesù, 7 | |
Catania, Italy, 95123 | |
UO di Medicina 'Valentini' - PO 'Annunziata' | |
Cosenza, Italy, 87100 | |
Angiologia - Ospedale di Faenza | |
Faenza, Italy | |
Divisione Medica II - Ospedale Galliera | |
Genova, Italy, 16128 | |
Centro Emofilia e Trombosi - Ospedale Maggiore di Milano IRCCS | |
Milano, Italy | |
Clinica Medica II - Università di Padova | |
Padua, Italy | |
Unità malattie tromboemboliche ed emorragiche - Azienda universitaria Policlinico | |
Palermo, Italy | |
Internal and Cardiovascular Medicine - University of Perugia | |
Perugia, Italy | |
Medicina Interna I - Arcispedale S. Maria Nuova | |
Reggio Emilia, Italy, 42100 | |
Divisione Medica I, Ospedale Cà Foncello | |
Treviso, Italy, 31100 | |
Medicina d'Urgenza - Ospedale Cattinara | |
Trieste, Italy, 34100 | |
Department of Medicina Interna e Terapia Medica, Università dell'Insubria | |
Varese, Italy |
Study Chair: | Giancarlo Agnelli, MD | Department of Internal Medicine - University of Perugia | |
Study Director: | Cecilia Becattini, MD | Department of Internal Medicine - University of Perugia | |
Study Director: | Paolo Prandoni, PhD | University of Padova |
Responsible Party: | Cecilia Becattini, DR, University Of Perugia |
ClinicalTrials.gov Identifier: | NCT00222677 |
Other Study ID Numbers: |
CRU-UniPg-01-03 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | August 23, 2011 |
Last Verified: | August 2011 |
venous thromboembolism deep vein thrombosis pulmonary embolism antithrombotic agents |
Pulmonary Embolism Thrombosis Atherosclerosis Thromboembolism Embolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Lung Diseases Respiratory Tract Diseases Aspirin |
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