Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice

Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03847181

Acronym

SiERRA UK

Enrollment

45164

Registered

2019-02-20

Start date

2019-02-28

Completion date

2020-10-31

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Oral anticoagulants, Under-dosing, Stroke prevention in atrial fibrillation, Safety, Effectiveness

Brief summary

This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as treatment for Stroke Prevention in Atrial Fibrillation (SPAF). Purpose of the study is to learn more about the safety and how well the drugs rivaroxaban, apixaban and warfarin work in patients appropriately and inappropriately receiving standard and reduced doses of each drug for reducing the risk of stroke in atrial fibrillation. Real world data from routine general practice stored in the primary care database in the UK, The Health Improvement Network (THIN), will be used for investigation.

Detailed description

Primary objectives are to assess the safety and effectiveness of rivaroxaban, apixaban and warfarin 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.

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban at a dose of 15 or 20 mg once daily

DRUGApixaban (Eliquis)

Apixaban at a dose of 2.5 or 5 mg twice daily

DRUGWarfarin

Warfarin dose as prescribed by medical practitioner

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with non-valvular atrial fibrillation * New users of rivaroxaban, apixaban or warfarin * At least one year enrollment with the general practice (GP) * One year since first health contact recorded in THIN prior to the first prescription of a study drug

Exclusion criteria

* Patients with other recent indications of oral anticoagulant initiation * Individuals on more than one oral anticoagulant on the start date * Users of rivaroxaban apart from 15 / 20 mg daily dose * Users of apixaban apart from 5 / 10 mg daily dose

Design outcomes

Primary

Measure	Time frame	Description
Risk of intracranial hemorrhage	Retrospective analysis of data from 2012 to 2017	Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Risk of ischemic events	Retrospective analysis of data from 2012 to 2017	Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.

Secondary

Measure	Time frame	Description
Risk of intracranial hemorrhage in NVAF-patients with diabetes	Retrospective analysis of data from 2012 to 2017	Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Risk of ischemic events in NVAF-patients with diabetes	Retrospective analysis of data from 2012 to 2017	Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
All-cause mortality	Retrospective analysis of data from 2012 to 2017	Rate of deaths from all causes.
Risk of intracranial hemorrhage in NVAF-patients with renal impairment	Retrospective analysis of data from 2012 to 2017	Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Drug utilisation after first intracranial hemorrhage or ischemic stroke	Retrospective analysis of data from 2012 to 2017	Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.
Patient characteristics	Retrospective analysis of data from 2012 to 2017	Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.
Patient characteristics after first intracranial hemorrhage or ischemic stroke	Retrospective analysis of data from 2012 to 2017	Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.
Drug utilisation	Retrospective analysis of data from 2012 to 2017	Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.
Risk of ischemic events in NVAF-patients with renal impairment	Retrospective analysis of data from 2012 to 2017	Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026