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Aspirin for the Prevention of Recurrent Venous Thromboembolism

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Cecilia Becattini, University Of Perugia.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222677
First Posted: September 22, 2005
Last Update Posted: August 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cecilia Becattini, University Of Perugia
  Purpose
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

Condition Intervention Phase
Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolism Atherosclerosis Drug: aspirin Phase 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Cecilia Becattini, University Of Perugia:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: May 2004
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aspirin
    100 mg daily
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
University Of Perugia
Investigators
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 Padua
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecilia Becattini, DR, University Of Perugia
ClinicalTrials.gov Identifier: NCT00222677     History of Changes
Other Study ID Numbers: CRU-UniPg-01-03
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by Cecilia Becattini, University Of Perugia:
venous thromboembolism
deep vein thrombosis
pulmonary embolism
antithrombotic agents

Additional relevant MeSH terms:
Thrombosis
Atherosclerosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lung Diseases
Respiratory Tract Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics