ClinicalTrials.gg
Status unknownNCT04007653HOKUSAIpostVTEUpdated Jul 5, 2019

Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE

An observational study in Venous Thromboembolic Disease, Post Thrombotic Syndrome and Chronic Thromboembolic Pulmonary Hypertension, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,200
Sex
All
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Study 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. 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.

02

Conditions studied

  • 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
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In context

Postthrombotic Syndrome

67 studies on the registry are indexed under Postthrombotic Syndrome; 22 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 294 across 22 observational studies indexed under Postthrombotic Syndrome.

Browse Postthrombotic Syndrome studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant in the HOKUSAI VTE trial

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Other: Observation

Interventions

  • OtherObservation

    No intervention

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What researchers measure

Primary outcomes

  1. Post thrombotic syndrome (PTS)

    PTS according to Villalta

    Time frame: up to 10 years

Secondary outcomes

  1. Chronic thromboembolic pulmonary hypertension (CTEPH)

    according to clinical and objective criteria

    Time frame: up to 10 years

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Study locations

1 of 1 sites recruiting
  • Academisch Medisch Centrum
    Amsterdam, 1105 AZ, Netherlands
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04007653
Responsible party
S. Middeldorp (Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Jul 5, 2019
Start date
Apr 25, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 5, 2019

Study contacts

Ingrid Bistervels, MD
Contact
i.m.bistervels@amc.uva.nl
+31205665976
Roisin Bavalia, MD
Contact
r.bavalia@amc.uva.nl
0031 205667516

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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