SiERRA UK: 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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| NVAF-patients_1 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. |
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban at a dose of 15 or 20 mg once daily
Other Names:
|
| NVAF-patients_2 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. |
Drug: Apixaban (Eliquis)
Apixaban at a dose of 2.5 or 5 mg twice daily
Other Names:
|
| NVAF-patients_3 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. |
Drug: Warfarin
Warfarin dose as prescribed by medical practitioner
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- All-cause mortality [Retrospective analysis of data from 2012 to 2017]
Rate of deaths from all causes.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with non-valvular atrial fibrillation
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New users of rivaroxaban, apixaban or warfarin
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At least one year enrollment with the general practice (GP)
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One year since first health contact recorded in THIN prior to the first prescription of a study drug
Exclusion Criteria:
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Patients with other recent indications of oral anticoagulant initiation
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Individuals on more than one oral anticoagulant on the start date
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Users of rivaroxaban apart from 15 / 20 mg daily dose
-
Users of apixaban apart from 5 / 10 mg daily dose
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many facilities | Many Sites | United Kingdom |
Sponsors and Collaborators
- Bayer
- Janssen, LP
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20343
- EUPAS28234