Venous Thromboembolic DiseaseHOKUSAIpostVTENCT04007653
Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE
An observational study of Venous Thromboembolic Disease and Post Thrombotic Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolic Disease, Post Thrombotic Syndrome, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Observation
- How many people
- 1,200 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Apr 2017to 31 Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.
Who may be able to join
- Participant in the HOKUSAI VTE trial
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academisch Medisch Centrum
Amsterdam, 1105 AZ
About this study
The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.
- Conditions
- Venous Thromboembolic Disease, Post Thrombotic Syndrome, Chronic Thromboembolic Pulmonary Hypertension, Quality of Life
- Being tested
- Observation
- Keywords
- Post thrombotic syndrome, Edoxaban, Vitamin K antagonist, Chronic Thromboembolic Pulmonary Hypertension, Quality of Life
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with heparin+edoxaban for VTE | Patients treated with heparin+edoxaban for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised. Receives: Other: Observation | |
| Patients treated with heparin+VKA for VTE | Patients treated with heparin+VKA for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post thrombotic syndrome (PTS)
PTS according to Villalta
Measured: up to 10 years
Secondary outcomes (1)
Chronic thromboembolic pulmonary hypertension (CTEPH)
according to clinical and objective criteria
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start25 Apr 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S. Middeldorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007653
- Sponsor's protocol ID
- HOKUSAI post VTE study
- Acronym
- HOKUSAIpostVTE
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE
- ClinicalTrials.gov ID
- NCT04007653
- Acronym / sponsor ID
- HOKUSAIpostVTE / HOKUSAI post VTE study
- Conditions
- Venous Thromboembolic Disease, Post Thrombotic Syndrome, Chronic Thromboembolic Pulmonary Hypertension, Quality of Life
- Keywords
- Post thrombotic syndrome, Edoxaban, Vitamin K antagonist, Chronic Thromboembolic Pulmonary Hypertension, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Jul 2019 (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.
The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with heparin+edoxaban for VTE | – | Other: ObservationPatients treated with heparin+edoxaban for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised. |
| Patients treated with heparin+VKA for VTE | – | Other: ObservationPatients treated with heparin+VKA for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.
Key inclusion criteria (1 listed)
- Participant in the HOKUSAI VTE trial
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ObservationNo intervention | Other | Patients treated with heparin+VKA for VTE, Patients treated with heparin+edoxaban for VTE |
Primary outcome
Post thrombotic syndrome (PTS)
Time frame: up to 10 years
PTS according to Villalta
1 secondary outcome
Chronic thromboembolic pulmonary hypertension (CTEPH)
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolic Disease and Post Thrombotic Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Bistervels, MD (+31205665976, i.m.bistervels@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post thrombotic syndrome (PTS) (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.