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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

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.

Condition or disease
Stroke, Systemic Embolism, VTEt and VTEp

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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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
Study Start Date : August 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

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



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339818


Locations
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United States, New Jersey
Local Institution
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02339818    
Other Study ID Numbers: CV185-365
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases