Assessment of the effectiveness of risk minimisation measures set up for new safety information for Efient® (Prasugrel): a multinational survey among physicians to evaluate their knowledge and consideration of the new safety warning for Prasugrel in four European countries (H7T-MC-B021)

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

• Name of medicine, other:
  Effient
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• Short description of the study population:
  Physicians, prescribers, or potential prescribers, of Efient® (prasugrel); Specialists of any of those targeted for the Direct Healthcare Professional Communication (DHPC): cardiologists in all countries; physicians working in emergency departments, according to country specificities (cardiologists, emergency physicians, and physicians working in first aid).
• 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:
  442

Study design details

• Main study objective:
  To evaluate the proportion of targeted physicians who are knowledgeable of the new safety warning about Prasugrel.
• Outcomes:
  To evaluate the proportion of targeted physicians who are knowledgeable of the new safety warning about prasugrel. To evaluate whether the physicians will consider the safety warning when prescribing Efient® (prasugrel).
• Data analysis plan:
  The statistical analysis will be conducted using the SAS®softwareV9.3 on Windows™ (SAS Institute, North Carolina, USA).Statistical results of the four countries will be presented in the same report, overall, by country and physician’s specialty.Continuous variables will be described by their number (of valid cases, of missing values), mean, standard deviation, median, Q1, Q3, minimum and maximum.Categorical variables will be described as the total number and relative percentage per category. These will be the percentage per category.Confidence intervals of 95% will be calculated, when relevant.