Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP) - Full Text View

Sponsored by:	University Hospital, Brest
Information provided by:	University Hospital, Brest
ClinicalTrials.gov Identifier:	NCT00740493

Purpose

In a French multicenter double blind randomized controlled trial, the main objective is to demonstrate that, after 6 months of oral anticoagulation for a first episode of idiopathic proximal deep vein thrombosis, 18 months of warfarin therapy is associated with a lower cumulative risk of recurrent VTE and major bleeding in comparison with that on 18 months of placebo. The secondary objectives are: (1) to determine the risk of recurrent VTE after 6 months of warfarin therapy and the presence or the absence of residual lung scan perfusion defect and the persistence or not of elevated D-dimer test; and (2), to determine the impact of extended duration of anticoagulation on the risk of VTE after stopping anticoagulant therapy on a follow-up of 2 years.

Condition	Intervention	Phase
Recurrent Venous Thromboembolism Idiopathic Deep Vein Thrombosis	Drug: warfarin Drug: placebo of warfarin	Phase III

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Eighteen Months of Oral Anticoagulant Therapy Versus Placebo After 6 Six Months of Anticoagulation for a First Episode of Idiopathic Proximal Deep Vein Thrombosis: a Multicentre Double-Blind Randomized Controlled Trial. "PADIS-TVP" Study.

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:

symptomatic recurrent venous thromboembolism and serious bleedings [ Time Frame: validated standardized objective tests ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mortality due to another cause than recurrent venous thromboembolism or serious bleeding [ Time Frame: medical report and death certificates ] [ Designated as safety issue: No ]

Estimated Enrollment:	374
Study Start Date:	July 2007
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 18 months of active warfarin therapy	Drug: warfarin 18 months of warfarin therapy
2: Placebo Comparator 18 months of placebo of warfarin	Drug: placebo of warfarin 18 months of placebo of 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:

Patients with a first episode of idiopathic proximal deep vein thrombosis who have been treated during 6 months (Plus or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3.

Exclusion Criteria:

Age > 18
warfarin hypersensibility
unwilling or unable to give writting informed consent
distal deep vein thrombosis or pulmonary embolism
Proximal deep vein thrombosis which was provoked by a reversible major risk factor
major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden)
previous documented episode of proximale deep vein thrombosis or pulmonary embolism
other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve)
patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation
pregnancy
women without contraception
planned major surgery in the next 18 months
ongoing cancer or cured cancer in less than 2 years
serious bleeding risk (e.g.: gastric ulcer)
platelet count less than 100 Giga/l
Life expectancy less than 18 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740493

Contacts

Contact: Francis Couturaud, MD, PhD

33 2 98 34 73 36

francis.couturaud@chu-brest.fr

Locations

France
EA 3878	Recruiting
Brest, France, 29609
Contact: francis Couturaud, MD,PhD 33 2 98 34 73 36 francis.couturaud@chu-brest.fr

Sponsors and Collaborators

University Hospital, Brest

Investigators

Principal Investigator:

Francis Couturaud, MD, PhD

EA3878, IFR148

More Information

Responsible Party:	Brest University Hospital ( F. Couturaud )
Study ID Numbers:	RB06.019 PADIS TVP
Study First Received:	August 22, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740493
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee; France: Ministry of Health

Keywords provided by University Hospital, Brest:

recurrent venous thromboembolism
idiopathic deep vein thrombosis
optimal duration of anticoagulation

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Venous Thrombosis
Warfarin

Venous Thromboembolism
Recurrence
Thromboembolism
Thrombosis

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009