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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02339818

Enrollment

126

Registered

2015-01-15

Start date

2015-08-31

Completion date

2017-02-28

Last updated

2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Systemic Embolism, VTEt and VTEp

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)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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	At the time of completion of a survey (approximately 6 to 12 months)

Secondary

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	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	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	At the time of completion of a survey (approximately 6 to 12 months)

Countries

United States

Outcome results