Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE
NCT ID: NCT03757481
Last Updated: 2023-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2018-01-01
2020-03-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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no intervention
patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin
no intervention
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
Interventions
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no intervention
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patient under guardianship
18 Years
99 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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isabelle QUERE, PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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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, , France
Countries
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References
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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.
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.
Other Identifiers
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UF 7548
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL18_0005
Identifier Type: -
Identifier Source: org_study_id
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