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

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04007653
• Collaborator: (none)
• Enrollment: 1,200
• Location: 1
• Anticipated Duration (Months): 44.2
• Patients Per Site Per Month: 27.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolic Disease; Post Thrombotic Syndrome; Chronic Thromboembolic Pulmonary Hypertension; Quality of Life	Other: Observation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE
• Actual Study Start Date: Apr 25, 2017
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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.	Other: Observation; 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.	Other: Observation; No intervention

Outcome Measures

Primary Outcome Measures

1. Post thrombotic syndrome (PTS) [up to 10 years]

   PTS according to Villalta

Secondary Outcome Measures

1. Chronic thromboembolic pulmonary hypertension (CTEPH) [up to 10 years]

   according to clinical and objective criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant in the HOKUSAI VTE trial

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academisch Medisch Centrum	Amsterdam		Netherlands	1105 AZ

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S. Middeldorp, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT04007653
• Other Study ID Numbers: HOKUSAI post VTE study
• First Posted: Jul 5, 2019
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by S. Middeldorp, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): Post thrombotic syndrome; Edoxaban; Vitamin K antagonist; Chronic Thromboembolic Pulmonary Hypertension; Quality of Life
• Additional relevant MeSH terms: Hypertension, Pulmonary; Hypertension; Postthrombotic Syndrome; Postphlebitic Syndrome; Thromboembolism

Study Results

No Results Posted as of Jul 5, 2019