Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries

NCT ID: NCT02339818

Last Updated: 2017-03-08

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

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-02-28

Brief Summary

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The main purpose is to evaluate the effectiveness of the Eliquis® (apixaban) Prescriber Guide and Patient Alert Card in terms knowledge of the important identified risk of bleeding associated with Eliquis treatment communicated by the RM tools.

Detailed Description

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Observational Model, Other- This is a non-interventional, cross-sectional study in the EEA involving representative samples of HCPs who treat patients with Eliquis, as well as patients treated with Eliquis. This study will be facilitated via web-based surveys used to evaluate the effectiveness of the Eliquis Prescribe Guide and Patient Alert Card as risk management tools.

Enrollment: 384 Health Care Professions (HCPs) and 192 Patients

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults (VTEt)

Prevention of VTE in adult patients knee replacement surgery (VTEp)

Conditions

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Stroke, Systemic Embolism, VTEt and VTEp

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HCPs

HCPs involved in using Eliquis (apixaban)

No interventions assigned to this group

Patients

Patients taking Eliquis for any of the three currently approved indications

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HCP must have been involved in the treatment of at least one patient with Eliquis for any approved indication
* Patients must have taken Eliquis for any approved indication
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

Princeton, New Jersey, United States

Site Status

Countries

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United States

References

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Mayall S, Kahlon R, Al-Dakkak I, Shen SW. Evaluating the Effectiveness of Apixaban Additional Risk Minimisation Measures Using Surveys in Europe. Pharmaceut Med. 2021 Mar;35(2):123-135. doi: 10.1007/s40290-021-00380-1. Epub 2021 Mar 4.

Reference Type DERIVED
PMID: 33660230 (View on PubMed)

Related Links

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Other Identifiers

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CV185-365

Identifier Type: -

Identifier Source: org_study_id

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