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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.
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.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 1, 2018
Primary Completion Date
March 3, 2020
Completion Date
March 3, 2020
Last Updated
October 3, 2023
156
ACTUAL participants
no intervention
OTHER
Lead Sponsor
University Hospital, Montpellier
NCT07102160
NCT06519435
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06451003