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Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757481
Recruitment Status : Unknown
Verified January 2020 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : November 29, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Post Thrombotic Syndrome Deep Vein Thrombosis Chronic Thromboembolic Pulmonary Hypertension Other: no intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 437 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : October 17, 2020
Estimated Study Completion Date : October 17, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
no intervention
patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin
 Other: no intervention
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL


Outcome Measures
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Primary Outcome Measures :
  1. cumulative incidence of PTS in patients with an acute DVT [ Time Frame: 2 years ]
    PTS is defined by a Villalta index >5 or the presence of venous ulcer

  2. PE related quality of life [ Time Frame: 2 years after the index PE ]
    questionnaire SF 36


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient who participated in the HOKUSAI VTE trial

Exclusion Criteria:

  • patient deprived of liberty
  • patient under guardianship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757481


Contacts
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Contact: Guillemette TACONNET 0467335573 g-taconnet_decker@chu-montpellier.fr

Locations
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France
Amiens University Hospital Recruiting
Amiens, France
Contact: Marie-Antoinette SEVESTRE         
Angers University Hospital Recruiting
Angers, France
Contact: Pierre-Marie ROY         
Brest University Hospital Recruiting
Brest, France
Contact: Francis COUTURAUD         
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, France
Contact: Jeannot SCHMIDT         
Dijon University Hospital Recruiting
Dijon, France
Contact: Nicolas FALVO         
Grenoble University Hospital Recruiting
Grenoble, France
Contact: Gilles PERNOD         
Le Mans Hospital Recruiting
Le Mans, France
Contact: Karine MONTACLAR         
Montpellier University Hospital Recruiting
Montpellier, France
Contact: Isabelle QUERE         
Nice University Hospital Recruiting
Nice, France
Contact: Emile FERRARI         
APHP Hôpital Européen Georges Pompidou Recruiting
Paris, France
Contact: Olivier SANCHEZ         
Strasbourg University Hospital Recruiting
Strasbourg, France
Contact: Helena-Mihaela CORDEANU         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: isabelle QUERE, PH University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03757481    
Other Study ID Numbers: RECHMPL18_0005
UF 7548 ( Other Identifier: Montpellier University Hospital )
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases