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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836457
• Other study ID #: CV185-396
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Japan	Local Institution	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of all treatment-related adverse events ( AE)		52 Weeks
Primary	The incidence of serious adverse events (SAE)		52 Weeks
Primary	The incidence of unexpected treatment-related adverse events	The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events	52 Weeks
Primary	The incidence of bleeding	The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events	52 Weeks
Secondary	The incidence of venous thromboembolism (VTE)		52 Weeks

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form