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

Not Applicable

Completed

• Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis; Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Other: no intervention

• Registration Number: NCT03757481
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• patient who participated in the HOKUSAI VTE trial

Exclusion Criteria

• patient deprived of liberty
• patient under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
no intervention	no intervention	patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin

Primary Outcome Measures

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

Trial Locations

Locations (11)

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

Strasbourg University Hospital; 🇫🇷 Strasbourg, France

Nice University Hospital; 🇫🇷 Nice, France

Amiens University Hospital; 🇫🇷 Amiens, France

APHP Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France