Early Post-marketing Study of Eliquis (Apixaban)

NCT ID: NCT02153424

Last Updated: 2016-08-17

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-11-30

Brief Summary

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The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.

Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation (NVAF)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NVAF patients in Mexico treated with Apixaban

All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

Apixaban

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Other Intervention Names

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Eliquis

Eligibility Criteria

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Inclusion Criteria

* All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

Exclusion Criteria

* Subjects who received Apixaban as part of a clinical trial
* Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)
Minimum Eligible Age

18 Years

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

Guadalajara, Jalisco, Mexico

Site Status

Local Institution

Puebla City, Puebla, Mexico

Site Status

Countries

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Mexico

Related Links

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Other Identifiers

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CV185-330

Identifier Type: -

Identifier Source: org_study_id

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