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Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants (Exten-DACUS)

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. Identifier: NCT00623987
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : March 25, 2008
Information provided by:
Azienda Ospedaliera Universitaria Policlinico

Brief Summary:

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 or disease Intervention/treatment Phase
Deep Vein Thrombosis Drug: warfarin accordingly INR value Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 1999
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Recurrent Venous Thromboembolism [ Time Frame: for the entire study ]

Secondary Outcome Measures :
  1. major and minor haemorrhage, death [ Time Frame: for the entire study ]

Information from the National Library of Medicine

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

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)

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 identifier (NCT number): NCT00623987

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Sergio Siragusa
Palermo, Italy, 90127
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico
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Study Chair: Sergio Siragusa, MD University Hospital of Palermo
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sergio Siragusa, University of Palermo Identifier: NCT00623987    
Other Study ID Numbers: 0036/99
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008
Keywords provided by Azienda Ospedaliera Universitaria Policlinico:
Residual vein thrombosis
Optimal duration
Oral anticoagulants
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases