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

Atrial Fibrillation Clinical Trial

— SiERRA UK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847181
• Other study ID #: 20343
• Secondary ID: EUPAS28234
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45164
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban at a dose of 15 or 20 mg once daily
• Apixaban (Eliquis)
Apixaban at a dose of 2.5 or 5 mg twice daily
• Warfarin
Warfarin dose as prescribed by medical practitioner

Locations

Country	Name	City	State
United Kingdom	Many facilities	Many Sites

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen, LP

Country where clinical trial is conducted

United Kingdom, 

Outcome

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