Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP)
This study is currently recruiting participants.
Verified May 2013 by University Hospital, Brest
Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740493
First received: August 22, 2008
Last updated: May 16, 2013
Last verified: May 2013
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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:
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 2015 |
| Estimated Primary Completion Date: | November 2013 (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
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 | |
| CHRU de Brest | Recruiting |
| Brest, France, 29609 | |
| Contact: Francis COUTURAUD, MD,PhD 33 2 98 34 73 36 francis.couturaud@chu-brest.fr | |
| CHU de Grenoble | Active, not recruiting |
| Grenoble, France, 38043 | |
| Centre Hospitalier Pierre Le Damany | Recruiting |
| Lannion, France, 22303 | |
| Contact: Karine PROVOST, MD | |
| Centre Hospitalier de Bretagne Sud | Recruiting |
| Lorient, France, 56322 | |
| Contact: Serge BALEYNAUD, MD | |
| Centre Hospitalier Universitaire de Nantes | Active, not recruiting |
| Nantes, France, 44093 | |
| Hôpital Européen Georges Pompidou | Active, not recruiting |
| Paris, France, 75015 | |
| AP HP Hôpital Hôtel Dieu | Active, not recruiting |
| Paris, France, 75004 | |
| CHU de POITIERS | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Cédric LANDRON, MD | |
| Centre Hospitalier de Cornouaille | Active, not recruiting |
| Quimper, France, 29000 | |
| CHU de Rennes | Recruiting |
| Rennes, France, 35023 | |
| Contact: Patrick JEGO, PHD | |
| Centre Hospitalier de Saint Brieuc | Recruiting |
| Saint Brieuc, France, 22023 | |
| Contact: DUHAMEL, MD | |
| Hôpital de Rangueil | Active, not recruiting |
| Toulouse, France, 31000 | |
| CHU de Tours | Active, not recruiting |
| Tours, France, 37000 | |
| Centre Hospitalier Intercommunal | Recruiting |
| Vernon, France, 27200 | |
| Contact: Antoine ACHKAR, MD | |
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: | May 16, 2013 |
| 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 Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases |
Cardiovascular Diseases Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013