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 (SiERRA UK)

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban (Eliquis); Drug: Warfarin

Study type: Observational

Funder types: Industry

Identifiers

NCT03847181

EUPAS28234 (Other Identifier)

20343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45,164 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

45,164 participants in 3 patient groups

NVAF-patients_1

Description:

Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)

NVAF-patients_2

Description:

Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.

Treatment:

Drug: Apixaban (Eliquis)

NVAF-patients_3

Description:

Adult patients with non-valvular atrial fibrillation (NVAF) and one year health records in the British THIN-database, who have not yet used rivaroxaban, apixaban and warfarin.

Treatment:

Drug: Warfarin