- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04007653
Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE (HOKUSAIpostVTE)
July 2, 2019 updated by: S. Middeldorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ingrid Bistervels, MD
- Phone Number: +31205665976
- Email: i.m.bistervels@amc.uva.nl
Study Contact Backup
- Name: Roisin Bavalia, MD
- Phone Number: 0031 205667516
- Email: r.bavalia@amc.uva.nl
Study Locations
-
-
-
Amsterdam, Netherlands, 1105 AZ
- Recruiting
- Academisch Medisch Centrum
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.
Description
Inclusion Criteria:
- Participant in the HOKUSAI VTE trial
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
No intervention
|
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.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post thrombotic syndrome (PTS)
Time Frame: up to 10 years
|
PTS according to Villalta
|
up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic thromboembolic pulmonary hypertension (CTEPH)
Time Frame: up to 10 years
|
according to clinical and objective criteria
|
up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 25, 2017
Primary Completion (ANTICIPATED)
December 31, 2020
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 2, 2019
First Posted (ACTUAL)
July 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOKUSAI post VTE study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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