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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Warfarin Warfarin sodium

U.S. FDA Resources

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 Study Completion Date:	November 2017
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

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

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

Locations


France
CHRU de Brest
Brest, France, 29609
CHU de Grenoble
Grenoble, France, 38043
Centre Hospitalier Pierre Le Damany
Lannion, France, 22303
Centre Hospitalier de Bretagne Sud
Lorient, France, 56322
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44093
AP HP Hôpital Hôtel Dieu
Paris, France, 75004
Hôpital Européen Georges Pompidou
Paris, France, 75015
CHU de POITIERS
Poitiers, France, 86021
Centre Hospitalier de Cornouaille
Quimper, France, 29000
CHU de Rennes
Rennes, France, 35023
Centre Hospitalier de Saint Brieuc
Saint Brieuc, France, 22023
Hôpital de Rangueil
Toulouse, France, 31000
CHU de Tours
Tours, France, 37000
Centre Hospitalier Intercommunal
Vernon, France, 27200

Sponsors and Collaborators

University Hospital, Brest

Investigators


Principal Investigator:	Francis Couturaud, MD, PhD	EA3878, IFR148

More Information

No publications provided


Responsible Party:	University Hospital, Brest
ClinicalTrials.gov Identifier:	NCT00740493 History of Changes
Other Study ID Numbers:	RB06.019 PADIS TVP
Study First Received:	August 22, 2008
Last Updated:	January 26, 2015
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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

Additional relevant MeSH terms:


Thromboembolism Thrombosis Venous Thromboembolism Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis	Vascular Diseases Warfarin Anticoagulants Hematologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015