Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03757481
Other study ID # RECHMPL18_0005
Secondary ID UF 7548
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date March 3, 2020

Study information

Verified date September 2023
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
no intervention
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05003843 - BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis N/A
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Withdrawn NCT04136561 - Novel Strategy to Encourage Early Removal of Central Venous Catheters N/A
Completed NCT03420625 - Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices N/A
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Completed NCT02555111 - Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis. Phase 3
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Completed NCT01975090 - The SENTRY Clinical Study N/A
Completed NCT02037607 - Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures N/A
Not yet recruiting NCT01357941 - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) N/A
Completed NCT00720915 - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months N/A
Completed NCT00771303 - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed NCT00773448 - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism N/A
Completed NCT00244725 - Odiparcil For The Prevention Of Venous Thromboembolism Phase 2
Completed NCT00264277 - D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism Phase 4
Completed NCT00365950 - 3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE Phase 4
Completed NCT00182403 - Fixed Dose Heparin Study Phase 3
Completed NCT03682419 - Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL) N/A
Not yet recruiting NCT04981327 - The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis Phase 3
Recruiting NCT03240120 - A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism Phase 3