An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban (Xarelto®) for the Prevention of Stroke in Patients with AF, Treatment of DVT and PE, and the Prevention of Recurrent DVT and PE in the Secondary Care Hospital Setting in England and Wales (ROSE)

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

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Name of medicine:
  XARELTO
• Medical condition to be studied:
  Atrial fibrillation

  Deep vein thrombosis

  Pulmonary embolism

Population studied

• Short description of the study population:
  Rivaroxaban prescribed newuser adult patients (i.e. rivaroxaban naïve who may or may not be antithrombotic therapy naïve) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adult patients, requiring anticoagulation under normal conditions of use in the secondary care hospital setting.
• 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:
  3400

Study design details

• Main study objective:
  To monitor the short-term (up to 12 weeks) safety profile and drug utilisation of rivaroxaban as prescribed to patients for medical conditions requiring anticoagulation by specialist Healthcare Professionals in the secondary care hospital setting in England and Wales.
• Outcomes:
  To provide timely information for rivaroxaban users on the estimation of the cumulative incidence risk (separately) of haemorrhage (within gastrointestinal and urogenital organ sites (which meets the criteria for a major bleed) and all intracranial sites, 1.Prescriber/cohort accrual, type of prescriber, setting 2.Non-clinical reasons for prescribing, prognostic health factors, clinical risk factors for haemorrhage 3.Changes of health profile/adherence/treatment 4.Quantify risk of haemorrhage within GI/urogenital/intracranial sites for contextual cohort & within critical organ sites for both cohorts, major & non-major bleeds, other events.
• Data analysis plan:
  Data analysis will include • Response rates to describe recruitment • Hazard rates to explore the incidence of selected events • Descriptive analyses of baseline health profile of patients • Analysis of risk and incidence densities to describe the risk profile of events reported in patient subgroups of special interest