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Residual Vein Thrombosis Establishes the Optimal Duration of Oral Anticoagulants (DACUS)

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ClinicalTrials.gov Identifier: NCT00438230
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : February 22, 2007
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria Policlinico

Brief Summary:

ABSTRACT Background The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain . The present study addressed the possible role of the Residual Vein Thrombosis in assessing the need for a prolonged anticoagulation.

Methods Patients with a first episode of symptomatic unprovoked or provoked proximal Vein Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT did not continue OAT, whereas those with RVT will be randomized to either stop or continue OAT for 9 more months. Patients were followed-up prospectively focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of at least 12 months after OAT discontinuation.


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: Warfarin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Residual Vein Thrombosis (RVT) Establishes the Optimal Duration of Oral Anticoagulants After a First Episode of Deep Vein Thrombosis of the Lower Limbs
Study Start Date : November 2003
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Warfarin
U.S. FDA Resources




Primary Outcome Measures :
  1. Recurrent Venous Thromboembolism
  2. major and minor haemorrhage
  3. death


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 unprovoked and provoked proximal DVT of the lower limbs and treated for 3 month with oral anticoagulants

Exclusion Criteria:

  • Active cancer,
  • Limited life expectancy,
  • Antiphospholipid antibody syndrome, or an other known thrombophilic status (such as antithrombin deficiency),
  • Serious liver disease,
  • Renal insufficiency (serum creatinine > 2 mg/dL).

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): NCT00438230


Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico
Investigators
Study Chair: Sergio Siragusa, MD University Hospital of Palermo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00438230     History of Changes
Other Study ID Numbers: 000743
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: February 22, 2007
Last Verified: February 2007

Keywords provided by Azienda Ospedaliera Universitaria Policlinico:
Residual vein thrombosis
Optimal duration
Oral anticoagulants

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants