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

March 6, 2017 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Detailed Description

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)

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HCPs will be considered for participation in the study if they prescribe/use Eliquis for any approved indications, including the following subgroups as appropriate for each country:

  • Cardiologists (including allied specialties, e.g. angiologists, electrophysiologists)
  • Non-cardiology specialists (e.g. internal medicine/hospital general medicine physicians, geriatricians/care of the elderly physicians, neurologists, hematologists, orthopedic surgeons)
  • General practitioners/internal medicine
  • Other HCPs (e.g. nurses, pharmacists)
  • Patients taking Eliquis for all three currently approved indications

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HCPs
HCPs involved in using Eliquis (apixaban)
Patients
Patients taking Eliquis for any of the three currently approved indications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportions of HCPs using Eliquis and patients treated with Eliquis with knowledge of the important identified risk of bleeding associated with Eliquis treatment measured through web-based survey results
Time Frame: At the time of completion of a survey (approximately 6 to 12 months)
At the time of completion of a survey (approximately 6 to 12 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportions of HCPs using Eliquis and patients treated with Eliquis who have received the Risk minimization (RM) tools measured through web-based survey results
Time Frame: At the time of completion of a survey (approximately 6 to 12 months)
At the time of completion of a survey (approximately 6 to 12 months)
The proportions of HCPs using Eliquis and patients treated with Eliquis who have utilized the RM tools, and the extent of tool usage measured through web-based survey results
Time Frame: At the time of completion of a survey (approximately 6 to 12 months)
At the time of completion of a survey (approximately 6 to 12 months)
The levels and distributions of behavior questionnaire results for HCPs and patients measured through web-based survey results
Time Frame: At the time of completion of a survey (approximately 6 to 12 months)
At the time of completion of a survey (approximately 6 to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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