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Trial record 1 of 1 for:    NCT02339818
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Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries

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ClinicalTrials.gov Identifier: NCT02339818
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : March 8, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date January 13, 2015
First Posted Date January 15, 2015
Last Update Posted Date March 8, 2017
Study Start Date August 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2015)
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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 20, 2015)
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures
 (submitted: January 13, 2015)
  • The proportions of HCPs using Eliquis and patients treated with Eliquis who have received the RM tools measured through web-based survey results [ Time Frame: 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) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
Official Title Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
Brief 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.
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
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Stroke, Systemic Embolism, VTEt and VTEp
Intervention Not Provided
Study Groups/Cohorts
  • HCPs
    HCPs involved in using Eliquis (apixaban)
  • Patients
    Patients taking Eliquis for any of the three currently approved indications
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2017)
126
Original Estimated Enrollment
 (submitted: January 13, 2015)
576
Actual Study Completion Date February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02339818
Other Study ID Numbers CV185-365
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2017