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

NCT ID: NCT04007653

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-25

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolic Disease Post Thrombotic Syndrome Chronic Thromboembolic Pulmonary Hypertension Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observation

Intervention Type OTHER

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.

Observation

Intervention Type OTHER

No intervention

Interventions

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Observation

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant in the HOKUSAI VTE trial

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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S. Middeldorp

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Academisch Medisch Centrum

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Ingrid Bistervels, MD

Role: CONTACT

+31205665976

Roisin Bavalia, MD

Role: CONTACT

0031 205667516

Other Identifiers

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HOKUSAI post VTE study

Identifier Type: -

Identifier Source: org_study_id

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