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Completed

NCT Number: NCT02433366

Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 81, Dobrich, Bulgaria

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About this study

Purpose:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pradaxa® prescribers (cardiologists and primary care physicians)
  • Patients with atrial fibrillation treated with Pradaxa®

Exclusion criteria

As defined in Summary of Product Characteristics for patients treated with Pradaxa®

Treatment and study plan

Primary outcomes

  1. Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)

    Time frame: Day 1

    The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.

    This Outcome measure is applicable only for the Physicians group.

  2. Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)

    Time frame: Day 1

    The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 5, 2015
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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