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

Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Post Thrombotic Syndrome; Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patient who participated in the HOKUSAI VTE trial

Exclusion Criteria:

• patient deprived of liberty
• patient under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: no intervention; patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin	Other: no intervention; SF-36 questionnaire , PembQoL, Villalta score ,PembQoL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative incidence of PTS in patients with an acute DVT	PTS is defined by a Villalta index >5 or the presence of venous ulcer	2 years
PE related quality of life	questionnaire SF 36	2 years after the index PE

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: isabelle QUERE, PH, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Thrombosis; Venous Thrombosis; Hypertension, Pulmonary; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: RECHMPL18_0005; UF 7548 (Other Identifier: Montpellier University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No