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

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria Policlinico
ClinicalTrials.gov Identifier:
NCT00438230
First received: February 20, 2007
Last updated: February 21, 2007
Last verified: February 2007
History of Changes
  Purpose

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 Intervention Phase
Deep Vein Thrombosis
 Drug: Warfarin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Universitaria Policlinico:

Primary Outcome Measures:
  • Recurrent Venous Thromboembolism
  • major and minor haemorrhage
  • death

Estimated Enrollment: 250
Study Start Date: November 2003
Estimated Study Completion Date: September 2006
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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438230

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

No publications provided by Azienda Ospedaliera Universitaria Policlinico

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00438230     History of Changes
Other Study ID Numbers: 000743
Study First Received: February 20, 2007
Last Updated: February 21, 2007
Health Authority: Italy: National Bioethics Committee

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
 Anticoagulants
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013