Post Thrombotic SyndromeNCT03757481
Long-term Outcome After Heparin and Edoxaban Versus Heparin Plus Vit K Antagonists for Acute DVT and PE
A study of Post Thrombotic Syndrome and Deep Vein Thrombosis, run by University Hospital, Montpellier at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post Thrombotic Syndrome, Deep Vein Thrombosis, Chronic Thromboembolic Pulmonary Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Jan 2018to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who participated in the HOKUSAI VTE trial
Who cannot join
- patient deprived of liberty
- patient under guardianship
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Amiens University Hospital
Amiens
Angers University Hospital
Angers
Brest University Hospital
Brest
Clermont-Ferrand University Hospital
Clermont-Ferrand
Dijon University Hospital
Dijon
Grenoble University Hospital
Grenoble
Le Mans Hospital
Le Mans
Montpellier University Hospital
Montpellier
Nice University Hospital
Nice
APHP Hôpital Européen Georges Pompidou
Paris
Strasbourg University Hospital
Strasbourg
About this study
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
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.
Read the 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
- Post Thrombotic Syndrome, Deep Vein Thrombosis, Chronic Thromboembolic Pulmonary Hypertension
- Being tested
- no intervention
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Other | patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of PTS in patients with an acute DVT
PTS is defined by a Villalta index >5 or the presence of venous ulcer
Measured: 2 years
PE related quality of life
questionnaire SF 36
Measured: 2 years after the index PE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Jan 2018
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Thrombotic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- isabelle QUERE, PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757481
- Sponsor's protocol ID
- RECHMPL18_0005
- Other IDs
- UF 7548
- Status last verified
- Sep 2023
- First submitted
- 23 Nov 2018
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35992565Bavalia 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.
PubMed 34278193
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03757481
- Acronym / sponsor ID
- RECHMPL18_0005
- Conditions
- Post Thrombotic Syndrome, Deep Vein Thrombosis, Chronic Thromboembolic Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no intervention | Other | Other: no interventionpatients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient who participated in the HOKUSAI VTE trial
Key exclusion criteria (2 listed)
- patient deprived of liberty
- patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionSF-36 questionnaire , PembQoL, Villalta score ,PembQoL | Other | no intervention |
Primary outcome
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
PE related quality of life
Time frame: 2 years after the index PE
questionnaire SF 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 35992565Bistervels 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.
- Background: PubMed 34278193Bavalia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
isabelle QUERE, PH principal investigator
University Hospital, Montpellier
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Post Thrombotic Syndrome and Deep Vein Thrombosis, run by University Hospital, Montpellier at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of PTS in patients with an acute DVT (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757481, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.