ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE

The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time

Exclusion criteria

Prior treatment with Eliquis for nonvalvular atrial fibrillation or VTE
Patients initiating Eliquis for the treatment of atrial fibrillation
Off-label use of Eliquis

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Primary outcomes

The incidence of all treatment-related adverse events ( AE)

Time frame: 52 Weeks
The incidence of serious adverse events (SAE)

Time frame: 52 Weeks
The incidence of unexpected treatment-related adverse events

Time frame: 52 Weeks

The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events
The incidence of bleeding

Time frame: 52 Weeks

The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events

Secondary outcomes

The incidence of venous thromboembolism (VTE)

Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jul 19, 2016
Registry last updated: Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed