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
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT03847181
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45164
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NVAF-patients_1 Rivaroxaban (Xarelto, BAY59-7939) 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. NVAF-patients_2 Apixaban (Eliquis) 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. NVAF-patients_3 Warfarin 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
All-cause mortality Retrospective analysis of data from 2012 to 2017 Rate of deaths from all causes.
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.
Trial Locations
- Locations (1)
Many facilities
🇬🇧Many Sites, United Kingdom