Atrial FibrillationSiERRA UKNCT03847181
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
An observational study of Atrial Fibrillation, run by Bayer at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis) and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 45,164 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2019to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UK population sample representative for age, sex and geographic distribution
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Warfarin
- Keywords
- Oral anticoagulants, Under-dosing, Stroke prevention in atrial fibrillation, Safety, Effectiveness
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Also called Non-Vitamin K Oral Anticoagulant (NOAC)
Rivaroxaban at a dose of 15 or 20 mg once daily
Apixaban (Eliquis)Drug
Also called Non-Vitamin K Oral Anticoagulant (NOAC)
Apixaban at a dose of 2.5 or 5 mg twice daily
WarfarinDrug
Also called Vitamin K Antagonist
Warfarin dose as prescribed by medical practitioner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939) | |
| 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. Receives: Drug: Apixaban (Eliquis) | |
| 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. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of intracranial hemorrhage
Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Measured: Retrospective analysis of data from 2012 to 2017
Risk of ischemic events
Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
Measured: Retrospective analysis of data from 2012 to 2017
Secondary outcomes (9)
Risk of intracranial hemorrhage in NVAF-patients with renal impairment
Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Measured: Retrospective analysis of data from 2012 to 2017
Risk of ischemic events in NVAF-patients with renal impairment
Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
Measured: Retrospective analysis of data from 2012 to 2017
Risk of intracranial hemorrhage in NVAF-patients with diabetes
Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Measured: Retrospective analysis of data from 2012 to 2017
Risk of ischemic events in NVAF-patients with diabetes
Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
Measured: Retrospective analysis of data from 2012 to 2017
All-cause mortality
Rate of deaths from all causes.
Measured: Retrospective analysis of data from 2012 to 2017
Drug utilisation
Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.
Measured: Retrospective analysis of data from 2012 to 2017
Drug utilisation after first intracranial hemorrhage or ischemic stroke
Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.
Measured: Retrospective analysis of data from 2012 to 2017
Patient characteristics
Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.
Measured: Retrospective analysis of data from 2012 to 2017
Patient characteristics after first intracranial hemorrhage or ischemic stroke
Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.
Measured: Retrospective analysis of data from 2012 to 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start28 Feb 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847181
- Sponsor's protocol ID
- 20343
- Other IDs
- EUPAS28234
- Acronym
- SiERRA UK
- Status last verified
- Oct 2021
- First submitted
- 18 Feb 2019
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK
- ClinicalTrials.gov ID
- NCT03847181
- Acronym / sponsor ID
- SiERRA UK / 20343
- Conditions
- Atrial Fibrillation
- Keywords
- Oral anticoagulants, Under-dosing, Stroke prevention in atrial fibrillation, Safety, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45,164 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NVAF-patients_1 | – | Drug: 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 | – | Drug: 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 | – | Drug: WarfarinAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UK population sample representative for age, sex and geographic distribution
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Also: Non-Vitamin K Oral Anticoagulant (NOAC)Rivaroxaban at a dose of 15 or 20 mg once daily | Drug | NVAF-patients_1 |
| Apixaban (Eliquis)Also: Non-Vitamin K Oral Anticoagulant (NOAC)Apixaban at a dose of 2.5 or 5 mg twice daily | Drug | NVAF-patients_2 |
| WarfarinAlso: Vitamin K AntagonistWarfarin dose as prescribed by medical practitioner | Drug | NVAF-patients_3 |
Primary outcome
Risk of intracranial hemorrhage
Time frame: Retrospective analysis of data from 2012 to 2017
Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
Risk of ischemic events
Time frame: Retrospective analysis of data from 2012 to 2017
Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
9 secondary outcomes
Risk of intracranial hemorrhage in NVAF-patients with renal impairment
Time frame: Retrospective analysis of data from 2012 to 2017
Risk of ischemic events in NVAF-patients with renal impairment
Time frame: Retrospective analysis of data from 2012 to 2017
Risk of intracranial hemorrhage in NVAF-patients with diabetes
Time frame: Retrospective analysis of data from 2012 to 2017
Risk of ischemic events in NVAF-patients with diabetes
Time frame: Retrospective analysis of data from 2012 to 2017
All-cause mortality
Time frame: Retrospective analysis of data from 2012 to 2017
Drug utilisation
Time frame: Retrospective analysis of data from 2012 to 2017
Drug utilisation after first intracranial hemorrhage or ischemic stroke
Time frame: Retrospective analysis of data from 2012 to 2017
Patient characteristics
Time frame: Retrospective analysis of data from 2012 to 2017
Patient characteristics after first intracranial hemorrhage or ischemic stroke
Time frame: Retrospective analysis of data from 2012 to 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bayer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of intracranial hemorrhage (time frame: Retrospective analysis of data from 2012 to 2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.