Trials / Completed
CompletedNCT03757481
Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE
Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vitamin K Antagonists for Acute Deep Vein Thrombosis and Pulmonary Embolism HOKUSAÏ POST VT
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | no intervention | SF-36 questionnaire , PembQoL, Villalta score ,PembQoL |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-03-03
- Completion
- 2020-03-03
- First posted
- 2018-11-29
- Last updated
- 2023-10-03
Locations
11 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03757481. Inclusion in this directory is not an endorsement.