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

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ClinicalTrials.gov Identifier: NCT00740493
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : January 12, 2017
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
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 or disease Intervention/treatment Phase
Recurrent Venous Thromboembolism Idiopathic Deep Vein Thrombosis Drug: warfarin Drug: placebo of warfarin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : July 2007
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. symptomatic recurrent venous thromboembolism and serious bleedings [ Time Frame: validated standardized objective tests ]

Secondary Outcome Measures :
  1. mortality due to another cause than recurrent venous thromboembolism or serious bleeding [ Time Frame: medical report and death certificates ]

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:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00740493

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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
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
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Principal Investigator: Francis Couturaud, MD, PhD EA3878, IFR148
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00740493    
Other Study ID Numbers: RB06.019 PADIS TVP
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Keywords provided by University Hospital, Brest:
recurrent venous thromboembolism
idiopathic deep vein thrombosis
optimal duration of anticoagulation
Additional relevant MeSH terms:
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Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases