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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Venous Thromboembolism Idiopathic Deep Vein Thrombosis | Drug: warfarin Drug: placebo of warfarin | Phase 3 |

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 |

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 |
- symptomatic recurrent venous thromboembolism and serious bleedings [ Time Frame: validated standardized objective tests ]
- mortality due to another cause than recurrent venous thromboembolism or serious bleeding [ Time Frame: medical report and death certificates ]

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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

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
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 |
Principal Investigator: | Francis Couturaud, MD, PhD | EA3878, IFR148 |
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 |
recurrent venous thromboembolism idiopathic deep vein thrombosis optimal duration of anticoagulation |
Thrombosis Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Warfarin Anticoagulants |