NCT02836457

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

February 21, 2022

Status Verified

January 1, 2022

Enrollment Period

2.1 years

First QC Date

July 12, 2016

Last Update Submit

February 3, 2022

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (4)

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

    52 Weeks

  • The incidence of serious adverse events (SAE)

    52 Weeks

  • 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

  • The incidence of bleeding

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

    52 Weeks

Secondary Outcomes (1)

  • The incidence of venous thromboembolism (VTE)

    52 Weeks

Study Arms (1)

Population with Exposure to ELIQUIS (APIXABAN)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Location

Related Links

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 19, 2016

Study Start

July 1, 2016

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

February 21, 2022

Record last verified: 2022-01

Locations

JP(1)