Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

June 3, 2022 updated by: Bristol-Myers Squibb

The primary objectives of this study are:

  • To estimate the incidence rate of unexpected adverse events
  • To characterize the bleeding events and assess risk factors of bleeding
  • To identify ancillary baseline variables that may also be associated with adverse outcomes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-0194
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

Exclusion Criteria:

  • Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eliquis on Nonvalvular Atrial Fibrilliation patients
Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study
Drug: Eliquis
Other Names:
  • Apixaban
  • BMS-562247

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of unexpected adverse events
Time Frame: Day 1 (At Eliquis initiation)
Day 1 (At Eliquis initiation)
Incidence rate of unexpected adverse events
Time Frame: 12 weeks after initiation
12 weeks after initiation
Incidence rate of unexpected adverse events
Time Frame: 52 weeks after initiation
52 weeks after initiation
Incidence rate of unexpected adverse events
Time Frame: 104 week (discontinuation)
104 week (discontinuation)
Bleeding events and risk factors of bleeding
Time Frame: Day 1 (At Eliquis initiation)
Day 1 (At Eliquis initiation)
Bleeding events and risk factors of bleeding
Time Frame: 12 weeks after initiation
12 weeks after initiation
Bleeding events and risk factors of bleeding
Time Frame: 52 weeks after initiation
52 weeks after initiation
Bleeding events and risk factors of bleeding
Time Frame: 104 week (discontinuation)
104 week (discontinuation)
Ancillary baseline variables that may also be associated with adverse outcomes
Time Frame: Day 1 (At Eliquis initiation)
Day 1 (At Eliquis initiation)
Ancillary baseline variables that may also be associated with adverse outcomes
Time Frame: 12 weeks after initiation
12 weeks after initiation
Ancillary baseline variables that may also be associated with adverse outcomes
Time Frame: 52 weeks after initiation
52 weeks after initiation
Ancillary baseline variables that may also be associated with adverse outcomes
Time Frame: 104 week (discontinuation)
104 week (discontinuation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

August 31, 2016

Study Completion (ACTUAL)

August 31, 2016

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-286

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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