Status:
COMPLETED
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
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen, LP
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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, api...
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, s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
45164 Patients enrolled
Trial Details
Trial ID
NCT03847181
Start Date
February 28 2019
End Date
October 31 2020
Last Update
October 28 2021
Active Locations (1)
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1
Many facilities
Many Sites, United Kingdom