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Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE

Primary Purpose

Post Thrombotic Syndrome, Deep Vein Thrombosis, Chronic Thromboembolic Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
no intervention
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Thrombotic Syndrome

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient who participated in the HOKUSAI VTE trial

Exclusion Criteria:

  • patient deprived of liberty
  • patient under guardianship

Sites / Locations

  • Amiens University Hospital
  • Angers University Hospital
  • Brest University Hospital
  • Clermont-Ferrand University Hospital
  • Dijon University Hospital
  • Grenoble University Hospital
  • Le Mans Hospital
  • Montpellier University Hospital
  • Nice University Hospital
  • APHP Hôpital Européen Georges Pompidou
  • Strasbourg University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

no intervention

Arm Description

patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin

Outcomes

Primary Outcome Measures

cumulative incidence of PTS in patients with an acute DVT
PTS is defined by a Villalta index >5 or the presence of venous ulcer
PE related quality of life
questionnaire SF 36

Secondary Outcome Measures

Full Information

First Posted
November 23, 2018
Last Updated
September 28, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03757481
Brief Title
Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE
Official Title
Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.
Detailed Description
HOKUSAI VTE trial was a randomised double blind non inferiority trial that compared the efficacy and safety of heparin ) (enoxaparin or unfractionated heparin) followed by edoxaban with heparin (enoxaparin or unfractionated heparin) followed by warfarin (target INR 2-3) in patients with acute, symptomatic VTE. Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE. patients with index DVT will be asked to complete the SF-36 and PembQoL questionnaire to assess the (venous disease-specific) quality of life. The Villalta score will be used to assess PTS. The objectively and subjectively obtained Villalta score- known as the patient reported Villalta -will be compared . Among patients with with an index PE, the QoL will be assessed bu the validated generic (SF-36) and DVT at index will be examined for PTS and will be asked to complete all questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Thrombotic Syndrome, Deep Vein Thrombosis, Chronic Thromboembolic Pulmonary Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no intervention
Arm Type
Other
Arm Description
patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
Primary Outcome Measure Information:
Title
cumulative incidence of PTS in patients with an acute DVT
Description
PTS is defined by a Villalta index >5 or the presence of venous ulcer
Time Frame
2 years
Title
PE related quality of life
Description
questionnaire SF 36
Time Frame
2 years after the index PE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient who participated in the HOKUSAI VTE trial Exclusion Criteria: patient deprived of liberty patient under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
isabelle QUERE, PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
Country
France
Facility Name
Angers University Hospital
City
Angers
Country
France
Facility Name
Brest University Hospital
City
Brest
Country
France
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
Country
France
Facility Name
Dijon University Hospital
City
Dijon
Country
France
Facility Name
Grenoble University Hospital
City
Grenoble
Country
France
Facility Name
Le Mans Hospital
City
Le Mans
Country
France
Facility Name
Montpellier University Hospital
City
Montpellier
Country
France
Facility Name
Nice University Hospital
City
Nice
Country
France
Facility Name
APHP Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
Strasbourg University Hospital
City
Strasbourg
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35992565
Citation
Bistervels IM, Bavalia R, Beyer-Westendorf J, Ten Cate-Hoek AJ, Schellong SM, Kovacs MJ, Falvo N, Meijer K, Stephan D, Boersma WG, Ten Wolde M, Couturaud F, Verhamme P, Brisot D, Kahn SR, Ghanima W, Montaclair K, Hugman A, Carroll P, Pernod G, Sanchez O, Ferrari E, Roy PM, Sevestre-Pietri MA, Birocchi S, Wik HS, Hutten BA, Coppens M, Naue C, Grosso MA, Shi M, Lin Y, Quere I, Middeldorp S; Hokusai PTS Investigators. Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin. Res Pract Thromb Haemost. 2022 Jul 1;6(5):e12748. doi: 10.1002/rth2.12748. eCollection 2022 Jul.
Results Reference
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PubMed Identifier
34278193
Citation
Bavalia R, Bistervels IM, Boersma WG, Quere I, Brisot D, Falvo N, Stephan D, Couturaud F, Schellong S, Beyer-Westendorf J, Montaclair K, Ghanima W, Ten Wolde M, Coppens M, Ferrari E, Sanchez O, Carroll P, Roy PM, Kahn SR, Meijer K, Birocchi S, Kovacs MJ, Hugman A, Ten Cate H, Wik H, Pernod G, Sevestre-Pietri MA, Grosso MA, Shi M, Lin Y, Hutten BA, Verhamme P, Middeldorp S; Hokusai post-PE study investigators. Quality of life in patients with pulmonary embolism treated with edoxaban versus warfarin. Res Pract Thromb Haemost. 2021 Jul 14;5(5):e12566. doi: 10.1002/rth2.12566. eCollection 2021 Jul.
Results Reference
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Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE

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