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

NCT00740493 | Completed Phase 3 DMC

• 1 other identifier: RB06.019 PADIS TVP
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 14

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.

Conditions

Recurrent Venous Thromboembolism; Idiopathic Deep Vein Thrombosis

Keywords

recurrent venous thromboembolism; idiopathic deep vein thrombosis; optimal duration of anticoagulation

Outcome Measures

Primary Outcomes (1)

• symptomatic recurrent venous thromboembolism and serious bleedings

  validated standardized objective tests

Secondary Outcomes (1)

• mortality due to another cause than recurrent venous thromboembolism or serious bleeding

  medical report and death certificates

Study Arms (2)

1

ACTIVE COMPARATOR

18 months of active warfarin therapy

Drug: warfarin

2

PLACEBO COMPARATOR

18 months of placebo of warfarin

Drug: placebo of warfarin

Interventions

warfarin DRUG

18 months of warfarin therapy

1

placebo of warfarin DRUG

18 months of placebo of warfarin therapy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (14)

CHRU de Brest

Brest, 29609, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier Pierre Le Damany

Lannion, 22303, France

Location

Centre Hospitalier de Bretagne Sud

Lorient, 56322, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

AP HP Hôpital Hôtel Dieu

Paris, 75004, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

CHU de POITIERS

Poitiers, 86021, France

Location

Centre Hospitalier de Cornouaille

Quimper, 29000, France

Location

CHU de Rennes

Rennes, 35023, France

Location

Centre Hospitalier de Saint Brieuc

Saint-Brieuc, 22023, France

Location

Hôpital de Rangueil

Toulouse, 31000, France

Location

CHU de Tours

Tours, 37000, France

Location

Centre Hospitalier Intercommunal

Vernon, 27200, France

Location

Related Publications (1)

• Couturaud F, Pernod G, Presles E, Duhamel E, Jego P, Provost K, Pan-Petesch B, Sollier CBD, Tromeur C, Hoffmann C, Bressollette L, Lorillon P, Girard P, Le Moigne E, Le Hir A, Guegan M, Laporte S, Mismetti P, Lacut K, Bosson JL, Bertoletti L, Sanchez O, Meyer G, Leroyer C, Mottier D; "PADIS-DVT" investigators. Six months versus two years of oral anticoagulation after a first episode of unprovoked deep-vein thrombosis. The PADIS-DVT randomized clinical trial. Haematologica. 2019 Jul;104(7):1493-1501. doi: 10.3324/haematol.2018.210971. Epub 2019 Jan 3.

  PMID: 30606789 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Francis Couturaud, MD, PhD

  EA3878, IFR148

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 25, 2008
• Study Start: July 1, 2007
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

FR (14)