Effectiveness, safety and efficiency of the use of vernakalant in the control of the rhythm of atrial fibrillation in the emergency. Cohort study (VERITA)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multicenter retrospective, post-authorization drug study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C01BG11) vernakalant

  vernakalant
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients diagnosed with atrial fibrillation received treatment with vernakalant, amiodarone, flecainide, propafenone or electrical cardioversion from 2012 to 2022.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Atrial fibrillation patients
• Estimated number of subjects:
  352

Study design details

• Main study objective:
  To evaluate the effectiveness and safety of vernakalant for the rhythm control of AF in the context of clinical practice, in comparison with its treatment alternatives.
• Outcomes:
  Percentage of patients with reversion to sinus rhythm in the first hour after treatment, - Percentage of patients with reversion to sinus rhythm in the first 12 hours/24 hours. - Percentage of patients requiring hospitalization. - Hospital stay - Percentage of patients with AF recurrence in the first 5 days/ 30 days/ 6 months
• Data analysis plan:
  The incidence in exposed (cohort treated with vernakalan and in non-exposed (treated with other cardioversión drug) will be calculated for each of the effectiveness variables. From these, the measures of association relative risk (RR), absolute risk reduction (RAR) and relative risk reduction (RRR) will be calculated for each of the variables, with their 95% CIs. The RR adjusted for comorbidities and prognostic factors will be estimated.