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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03757481
Study type Interventional
Source University Hospital, Montpellier
Contact
Status Completed
Phase N/A
Start date January 1, 2018
Completion date March 3, 2020

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