Overview

This trial is active, not recruiting.

Condition stroke, systemic embolism, vtet and vtep
Sponsor Bristol-Myers Squibb
Collaborator Pfizer
Start date August 2015
End date January 2017
Trial size 192 participants
Trial identifier NCT02339818, CV185-365

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
Arm
HCPs involved in using Eliquis (apixaban)
Patients taking Eliquis for any of the three currently approved indications

Primary Outcomes

Measure
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

Measure
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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of the Effectiveness of Eliquis ® (Apixaban) Risk Minimization Tools in European Economic Area (EEA) Countries
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)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.