Aspirin for the Prevention of Recurrent Venous Thromboembolism
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.
1 other identifier
interventional
70
2 countries
15
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 anticoagulant therapy in patients with idiopathic venous thromboembolism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedAugust 23, 2011
August 1, 2011
7.7 years
September 13, 2005
August 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence of VTE and/or VTE related death
at least 24 months per patient
Secondary Outcomes (1)
recurrent VTE+ death; cardiovascular events, bleeding events, critical ischemia of the lower limbs, mesenteric infarction, all cause mortality and newly diagnosed cancer
at least 24 months per patient
Interventions
100 mg daily
Eligibility Criteria
You may qualify if:
- first episode of symptomatic, objectively confirmed idiopathic proximal deep vein thrombosis and/or pulmonary embolism;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Department of Internal Medicine - University of Vienna
Vienna, A 1090, Austria
Unità di Aterosclerosi e Trombosi -Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, 71013, Italy
Divisione di Ematologia, Dipartimento di Medicina Interna - Università di Milano-Bicocca
Monza, Milano, Italy
Angiologia - Osp. Garibaldi - Piazza S. Maria del Gesù, 7
Catania, 95123, Italy
UO di Medicina 'Valentini' - PO 'Annunziata'
Cosenza, 87100, Italy
Angiologia - Ospedale di Faenza
Faenza, Italy
Divisione Medica II - Ospedale Galliera
Genova, 16128, Italy
Centro Emofilia e Trombosi - Ospedale Maggiore di Milano IRCCS
Milan, 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, 42100, Italy
Divisione Medica I, Ospedale Cà Foncello
Treviso, 31100, Italy
Medicina d'Urgenza - Ospedale Cattinara
Trieste, 34100, Italy
Department of Medicina Interna e Terapia Medica, Università dell'Insubria
Varese, Italy
Related Publications (2)
Flumignan CD, Nakano LC, Baptista-Silva JC, Flumignan RL. Antiplatelet agents for the treatment of deep venous thrombosis. Cochrane Database Syst Rev. 2022 Jul 25;7(7):CD012369. doi: 10.1002/14651858.CD012369.pub2.
PMID: 35876829DERIVEDBecattini C, Agnelli G, Schenone A, Eichinger S, Bucherini E, Silingardi M, Bianchi M, Moia M, Ageno W, Vandelli MR, Grandone E, Prandoni P; WARFASA Investigators. Aspirin for preventing the recurrence of venous thromboembolism. N Engl J Med. 2012 May 24;366(21):1959-67. doi: 10.1056/NEJMoa1114238.
PMID: 22621626DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
May 1, 2004
Primary Completion
January 1, 2012
Last Updated
August 23, 2011
Record last verified: 2011-08