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Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants (Exten-DACUS)

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria Policlinico
ClinicalTrials.gov Identifier:
NCT00623987
First received: February 19, 2008
Last updated: March 24, 2008
Last verified: March 2008
History of Changes
  Purpose

Background. The optimal duration of oral anticoagulant treatment in patients with idiopathic Deep Vein Thrombosis (DVT)of the lower limbs is still uncertain. Residual Vein Thrombosis (RVT) has been found able to establish the patient' risk for recurrent thrombotic events. In the present study we conducted a RVT-based therapeutic strategy, withholding OAT after 3 months in patients without RVT while continuing anticoagulants for at least additional 9 months in those in whom RVT persists.

Methods Patients with a first episode of symptomatic unprovoked 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 (Group B), whereas those with RVT will continue OAT for at least additional 9 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 accordingly INR value
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Absence of Residual Vein Thrombosis After an Episode of Unprovoked Deep Vein Thrombosis: Short-Term Anticoagulation is Safe.

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 [ Time Frame: for the entire study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • major and minor haemorrhage, death [ Time Frame: for the entire study ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: June 1999
Study Completion Date: January 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
warfarin treatment
 Drug: warfarin accordingly INR value
warfarin accordingly to INR value between 2.0-3.0
Other Name: warfarin
No Intervention: B
withholding warfarin therapy

  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 unprovoked 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,
  • Pregnancy
  • Conditions requiring anticoagulation (atrial fibrillation, etc)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623987

Locations
Italy
Sergio Siragusa
Palermo, Italy, 90127
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):

Responsible Party: Sergio Siragusa, University of Palermo
ClinicalTrials.gov Identifier: NCT00623987     History of Changes
Other Study ID Numbers: 0036/99
Study First Received: February 19, 2008
Last Updated: March 24, 2008
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 May 16, 2013