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OpenTrials
Completed

NCT Number: NCT02007655

Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

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

Completed

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Key information

Conditions

NonValvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Toyama, 930-0194, Japan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Eliquis

Drug

Other names: Apixaban, BMS-562247

Primary outcomes

  1. Incidence rate of unexpected adverse events

    Time frame: Day 1 (At Eliquis initiation)

  2. Incidence rate of unexpected adverse events

    Time frame: 12 weeks after initiation

  3. Incidence rate of unexpected adverse events

    Time frame: 52 weeks after initiation

  4. Incidence rate of unexpected adverse events

    Time frame: 104 week (discontinuation)

  5. Bleeding events and risk factors of bleeding

    Time frame: Day 1 (At Eliquis initiation)

  6. Bleeding events and risk factors of bleeding

    Time frame: 12 weeks after initiation

  7. Bleeding events and risk factors of bleeding

    Time frame: 52 weeks after initiation

  8. Bleeding events and risk factors of bleeding

    Time frame: 104 week (discontinuation)

  9. Ancillary baseline variables that may also be associated with adverse outcomes

    Time frame: Day 1 (At Eliquis initiation)

  10. Ancillary baseline variables that may also be associated with adverse outcomes

    Time frame: 12 weeks after initiation

  11. Ancillary baseline variables that may also be associated with adverse outcomes

    Time frame: 52 weeks after initiation

  12. Ancillary baseline variables that may also be associated with adverse outcomes

    Time frame: 104 week (discontinuation)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2013
Registry last updated
Jun 7, 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.

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