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

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757481
• Other study ID #: RECHMPL18_0005
• Secondary ID: UF 7548
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• patient who participated in the HOKUSAI VTE trial

Exclusion Criteria:

• patient deprived of liberty
• patient under guardianship

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Deep Vein Thrombosis
• Hypertension, Pulmonary
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• no intervention
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Dijon University Hospital	Dijon
France	Grenoble University Hospital	Grenoble
France	Le Mans Hospital	Le Mans
France	Montpellier University Hospital	Montpellier
France	Nice University Hospital	Nice
France	APHP Hôpital Européen Georges Pompidou	Paris
France	Strasbourg University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PE related quality of life	questionnaire SF 36	2 years after the index PE