NCT03757481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

2.2 years

First QC Date

November 23, 2018

Last Update Submit

September 28, 2023

Conditions

Post Thrombotic SyndromeDeep Vein ThrombosisChronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

no intervention

OTHER

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

Interventions

no interventionOTHER

SF-36 questionnaire , PembQoL, Villalta score ,PembQoL

no intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient who participated in the HOKUSAI VTE trial

You may not qualify if:

  • patient deprived of liberty
  • patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Amiens University Hospital

Amiens, France

Location

Angers University Hospital

Angers, France

Location

Brest University Hospital

Brest, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Dijon University Hospital

Dijon, France

Location

Grenoble University Hospital

Grenoble, France

Location

Le Mans Hospital

Le Mans, France

Location

Montpellier University Hospital

Montpellier, France

Location

Nice University Hospital

Nice, France

Location

APHP Hôpital Européen Georges Pompidou

Paris, France

Location

Strasbourg University Hospital

Strasbourg, France

Location

Related Publications (2)

  • 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.

    PMID: 35992565BACKGROUND

  • 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.

    PMID: 34278193BACKGROUND

MeSH Terms

Conditions

Postthrombotic SyndromeVenous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Study Officials

  • isabelle QUERE, PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

November 29, 2018

Study Start

January 1, 2018

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)