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
Verified date | September 2023 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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
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 |
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