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CompletedNCT02339818Updated Mar 8, 2017

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

An observational study in Stroke, Systemic Embolism, VTEt and VTEp, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-08.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
126
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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)

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Conditions studied

  • Stroke, Systemic Embolism, VTEt and VTEp

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In context

Embolism

707 studies on the registry are indexed under Embolism; 74 are open to participants now.

This study's enrollment of 126 is below the median of 353 across 310 observational studies indexed under Embolism.

Browse Embolism studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Eligibility criteria

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
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
126 participants (actual)
Patient registry
No

Groups and cohorts

  • HCPs

    HCPs involved in using Eliquis (apixaban)

  • Patients

    Patients taking Eliquis for any of the three currently approved indications

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What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

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Study locations

1 site
  • Local Institution
    Princeton, New Jersey 08540, United States
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References and documents

Publications

  • 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. PubMed 33660230 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02339818
Lead sponsor
Bristol-Myers Squibb
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jan 15, 2015
Start date
Aug 2015
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Mar 8, 2017

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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