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

• Conditions: Post Thrombotic Syndrome; Chronic Thromboembolic Pulmonary Hypertension; Quality of Life; Venous Thromboembolic Disease
• Interventions: Other: Observation

• Registration Number: NCT04007653
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-25
• Status Verified: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Participant in the HOKUSAI VTE trial

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with heparin+edoxaban for VTE	Observation	Patients 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	Observation	Patients treated with heparin+VKA for a venous thromboembolic event during the HOKUSAI trial, for which they were randomised.

Primary Outcome Measures

Name	Time	Method
Post thrombotic syndrome (PTS)	up to 10 years	PTS according to Villalta

Secondary Outcome Measures

Name	Time	Method
Chronic thromboembolic pulmonary hypertension (CTEPH)	up to 10 years	according to clinical and objective criteria

Trial Locations

Locations (1)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands