Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RIVAROXABAN
• Anatomical Therapeutic Chemical (ATC) code:
  (B01A) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS
• Medical condition to be studied:
  Anticoagulant therapy

Population studied

• Short description of the study population:
  Physicians and patients with recent rivaroxaban experience.; Physicians were eligible to participate if they had prescribed rivaroxaban in the past 6 months for one of the indications of interest.; Patients were eligible if they had taken rivaroxaban within the last 3 months for one of the indications of interest.; ; Patients will be identified through selection of a diverse set of medical practices across the five targeted countries. To be eligible for the study, the patients must meet all of the following criteria:; 1. Patient has taken rivaroxaban within the last 3 months for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (SPAF) or treatment of DVT and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.; 2. Patient is aged 18 years or older.; 3. Patient is able to understand and complete the consent form and patient questionnaire.; 4. Patient can read and understand the native language of the country in which the study is being conducted.; 5. Patient has not participated in a clinical trial for a treatment to prevent blood clots in the past 12 months.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  The main objective of this cross-sectional epidemiologic study is to measure physician and patient awareness and understanding of the key messages in the prescriber guide and patient alert card.
• Outcomes:
  1) Knowledge and understanding among physicians regarding key safety information contained in the prescriber guide assessed by web-based questionnaire.2) Knowledge and understanding of patients regarding the key safety information contained in the patient alert card assessed by paper-based questionnaire.
• Data analysis plan:
  Analyses will include detailed review of responses to individual questions as well as potential summary measure across logical grouping of response items. Physician results will bestratified by country, speciality, and other logical variables. Patient results will be stratified by country and other logical variables, potentially including a measure of the knowledgelevel of their physician. A detailed analysis plan describing methods of analysis and presentation, as well as table shells, will be developed prior to starting analysis of data.

Documents

Study results

16167_EU PAS Abstract_Redacted_V 1.0_2020-06-09

Study report

16167_Clinical Study Report_Wave III_redacted_V 1.0_2020-06-09

16167_Clinical Study Report_Wave II_redacted_V 1.0_ 2018-05-24

16167_Clinical Study Report_Wave I_redacted_V 1.0_2015-10-16

16167_progress report

RTI EUPAS3911 - Summary Interim Report

Study, other information

16167_Protocol_V2_Wave I_redacted

16167_Clinical Study Report_Wave II_redacted_V 1.0_ 2018-05-24.pdf

16167_Clinical Study Report_Wave I_redacted_V 1.0_2015-10-16.pdf

16167_progress report.pdf

RTI EUPAS3911 - Summary Interim Report.pdf