Clinical trial NCT03847181: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Oral anticoagulants
Under-dosing
Stroke prevention in atrial fibrillation
Safety
Effectiveness
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen, LP
First posted: 2019-02-20
Enrollment: 45164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UK population sample representative for age, sex and geographic distribution

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk of intracranial hemorrhage
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Risk of ischemic events
timeFrame: Retrospective analysis of data from 2012 to 2017
Secondary outcomes:
measure: Risk of intracranial hemorrhage in NVAF-patients with renal impairment
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Risk of ischemic events in NVAF-patients with renal impairment
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Risk of intracranial hemorrhage in NVAF-patients with diabetes
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Risk of ischemic events in NVAF-patients with diabetes
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: All-cause mortality
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Drug utilisation
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Drug utilisation after first intracranial hemorrhage or ischemic stroke
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Patient characteristics
timeFrame: Retrospective analysis of data from 2012 to 2017
measure: Patient characteristics after first intracranial hemorrhage or ischemic stroke
timeFrame: Retrospective analysis of data from 2012 to 2017
Other outcomes:
Locations:
city: Many Sites
country: United Kingdom
facility: Many facilities
Study officials:
References: