Trial Condition(s):
Atrial Fibrillation
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 Identifier:
20343
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 drugExclusion 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 doseTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many facilities Many sites, United Kingdom | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Safety and effectiveness of rivaroxaban and apixaban compared to warfarin in non-valvular atrial fibrillation patients in the routine clinical practice in the UK
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- Risk of intracranial hemorrhageIntracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.Timeframe: Retrospective analysis of data from 2012 to 2017
- Risk of ischemic eventsIschemic events include ischaemic stroke / systemic embolism and myocardial infarction.Timeframe: Retrospective analysis of data from 2012 to 2017
Secondary Outcome
- Risk of intracranial hemorrhage in NVAF-patients with renal impairmentIntracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.Timeframe: Retrospective analysis of data from 2012 to 2017
- Risk of ischemic events in NVAF-patients with renal impairmentIschemic events include ischaemic stroke / systemic embolism and myocardial infarction.Timeframe: Retrospective analysis of data from 2012 to 2017
- Risk of intracranial hemorrhage in NVAF-patients with diabetesIntracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.Timeframe: Retrospective analysis of data from 2012 to 2017
- Risk of ischemic events in NVAF-patients with diabetesIschemic events include ischaemic stroke / systemic embolism and myocardial infarction.Timeframe: Retrospective analysis of data from 2012 to 2017
- All-cause mortalityRate of deaths from all causes.Timeframe: Retrospective analysis of data from 2012 to 2017
- Drug utilisationDrug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.Timeframe: Retrospective analysis of data from 2012 to 2017
- Drug utilisation after first intracranial hemorrhage or ischemic strokeDrug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.Timeframe: Retrospective analysis of data from 2012 to 2017
- Patient characteristicsPatient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.Timeframe: Retrospective analysis of data from 2012 to 2017
- Patient characteristics after first intracranial hemorrhage or ischemic strokePatient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.Timeframe: Retrospective analysis of data from 2012 to 2017
Additional Information
Not Available
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