Safety and Effectiveness of Rivaroxaban and Apixaban compared to warfarin in non-valvular atrial fibrillation patients in the routine clinical practice in the UK (SiERRA UK)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43877
• EU PAS number:
  EUPAS28234
• Study ID:
  43877
• Official title and acronym:
  Safety and Effectiveness of Rivaroxaban and Apixaban compared to warfarin in non-valvular atrial fibrillation patients in the routine clinical practice in the UK (SiERRA UK)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A recent cohort study in the UK showed that amongst patients with a history of non-valvular atrial fibrillation (NVAF) using non-vitamin K antagonists oral anti-coagulants (NOAC) without an apparent indication for dose reduction, the reduced dose was prescribed in approximately 30% of patients receiving apixaban and 10% of patients receiving rivaroxaban in the new users of both-agents. We hypothesize that patients dosed inappropriately could have higher rates of stroke and systemic embolism or bleeding. This population-based retrospective cohort study investigates safety and effectiveness in new users of rivaroxaban and apixaban versus new users of warfarin in a cohort of non-valvular atrial fibrillation (NVAF) patients from the THIN database (secondary data) in the UK, who received appropriately and inappropriately standard and reduced doses of each drug in accordance with the label. Safety and effectiveness of rivaroxaban, apixaban and warfarin are assessed based on the risk of intracranial hemorrhage and hemorrhagic strokes (safety) and ischemic stroke, systemic embolism and myocardial infarction (effectiveness). Secondary objectives comprise the assessment of the mentioned risks in subpopulations of patients with renal impairment or diabetes, mortality rates, and drug utilisation as well as patient characteristics before and after the first intracranial hemorrhage or ischemic stroke.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Study timelines

Date when funding contract was signed

Actual: 03/01/2019

Study start date

Planned: 28/02/2019

Actual: 28/02/2019

Date of final study report

Planned: 31/07/2021

Actual: 22/09/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

Study 20343_Study protocol_v1.0_2018-11-12_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable