Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP) (PADIS TVP)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00740493 |
|
Recruitment Status :
Completed
First Posted : August 25, 2008
Last Update Posted : January 12, 2017
|
Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Show Detailed Description
| 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 :
- symptomatic recurrent venous thromboembolism and serious bleedings [ Time Frame: validated standardized objective tests ]
Secondary Outcome Measures :
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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
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 |
| Responsible Party: | University Hospital, Brest |
| ClinicalTrials.gov Identifier: | NCT00740493 History of Changes |
| 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:
|
Thrombosis Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Warfarin Anticoagulants |