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

NCT ID: NCT02836457

Last Updated: 2022-02-21

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

1134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Population with Exposure to ELIQUIS (APIXABAN)

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Shinjuku-ku, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CV185-396

Identifier Type: -

Identifier Source: org_study_id

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