Status: Ongoing First registered on: 18/02/2019
Last updated on: 18/02/2020
1. Study identification
EU PAS Register NumberEUPAS28234
Official titleSafety and effectiveness of rivaroxaban and apixaban compared to warfarin in non-valvular atrial fibrillation patients in the routine clinical practice in the UK
Study title acronymSiERRA UK
Study typeObservational study
Brief description of the studyA recent cohort study in the UK showed that amongst patients with a history of non-valvular atrial fibrillation (NVAF) using non-vitamin K antagonists oral anti-coagulants (NOAC) without an apparent indication for dose reduction, the reduced dose was prescribed in approximately 30% of patients receiving apixaban and 10% of patients receiving rivaroxaban in the new users of both-agents. We hypothesize that patients dosed inappropriately could have higher rates of stroke and systemic embolism or bleeding. This population-based retrospective cohort study investigates safety and effectiveness in new users of rivaroxaban and apixaban versus new users of warfarin in a cohort of non-valvular atrial fibrillation (NVAF) patients from the THIN database (secondary data) in the UK, who received appropriately and inappropriately standard and reduced doses of each drug in accordance with the label. Safety and effectiveness of rivaroxaban, apixaban and warfarin are assessed 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEIFE
Department/Research groupFundación Centro Español de Investigación Farmacoepidemiológica
Organisation/affiliationFundación CEIFE
Website/Homepagewww.ceife.es
Details of (Primary) lead investigator
Title Dr
Last name García Rodríguez
First name Luis Alberto
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/01/2019
Start date of data collection28/02/201928/02/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name García Rodríguez
First name Luis Alberto
Address line 1Almirante 28
Address line 2 
Address line 3 
CityMadrid 
Postcode28004 
CountrySpain
Phone number (incl. country code)34915313404 
Alternative phone number 
Fax number (incl. country code)34915312871 
Email address lagarcia@ceife.es
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials 
Address line 1Muellerstrasse 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address Clinical-Trials-Contact@bayer.com 
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