Clinical trial NCT03757481: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Thrombotic Syndrome
Deep Vein Thrombosis
Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* patient who participated in the HOKUSAI VTE trial

Exclusion Criteria:

* patient deprived of liberty
* patient under guardianship

Primary outcomes:
measure: cumulative incidence of PTS in patients with an acute DVT
timeFrame: 2 years
measure: PE related quality of life
timeFrame: 2 years after the index PE
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Dijon
country: France
facility: Dijon University Hospital
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Le Mans
country: France
facility: Le Mans Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nice
country: France
facility: Nice University Hospital
city: Paris
country: France
facility: APHP Hôpital Européen Georges Pompidou
city: Strasbourg
country: France
facility: Strasbourg University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: isabelle QUERE, PH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.