Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

NCT ID: NCT02007655

Last Updated: 2022-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-01

Study Completion Date

2016-08-31

Brief Summary

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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

Detailed Description

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Conditions

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NonValvular Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Eliquis

Intervention Type DRUG

Interventions

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Eliquis

Intervention Type DRUG

Other Intervention Names

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Apixaban BMS-562247

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Toyama, Toyama, Japan

Site Status

Countries

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Japan

References

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Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M. Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study. J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15.

Reference Type DERIVED
PMID: 31421933 (View on PubMed)

Related Links

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Other Identifiers

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CV185-286

Identifier Type: -

Identifier Source: org_study_id

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