Aspirin for the Prevention of Recurrent Venous Thromboembolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Of Perugia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cecilia Becattini, University Of Perugia
ClinicalTrials.gov Identifier:
NCT00222677
First received: September 13, 2005
Last updated: August 21, 2011
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University Of Perugia:

Primary Outcome Measures:
  • recurrence of VTE and/or VTE related death [ Time Frame: at least 24 months per patient ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Of Perugia

Additional 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
Study First Received: September 13, 2005
Last Updated: August 21, 2011
Health Authority: Italy: The Italian Medicines Agency
Italy: National Institute of Health

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

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Embolism
Venous Thromboembolism
Venous Thrombosis
Pulmonary Embolism
Thromboembolism
Thrombosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on September 16, 2014