Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants - Full Text View

Sponsored by:	Azienda Ospedaliera Universitaria Policlinico
Information provided by:	Azienda Ospedaliera Universitaria Policlinico
ClinicalTrials.gov Identifier:	NCT00623987

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium

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
A: Active Comparator warfarin treatment	Drug: warfarin accordingly INR value warfarin accordingly to INR value between 2.0-3.0
B: No Intervention withholding warfarin therapy

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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 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

Responsible Party:	University of Palermo ( Sergio Siragusa )
Study ID Numbers:	0036/99
Study First Received:	February 19, 2008
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00623987 History of Changes
Health Authority:	Italy: National Bioethics Committee

Keywords provided by Azienda Ospedaliera Universitaria Policlinico:

Residual vein thrombosis
Optimal duration
Oral anticoagulants

Study placed in the following topic categories:

Embolism and Thrombosis
Anticoagulants
Embolism
Vascular Diseases

Venous Thrombosis
Warfarin
Thrombosis

Additional relevant MeSH terms:

Embolism and Thrombosis
Anticoagulants
Therapeutic Uses
Hematologic Agents
Vascular Diseases

Cardiovascular Diseases
Venous Thrombosis
Warfarin
Pharmacologic Actions
Thrombosis

ClinicalTrials.gov processed this record on September 03, 2009