Skip to main content
OpenTrials
Completed

NCT Number: NCT03847181

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many facilities

Many Sites, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 drug

Exclusion 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 dose

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Rivaroxaban at a dose of 15 or 20 mg once daily

Other names: Non-Vitamin K Oral Anticoagulant (NOAC)

Apixaban (Eliquis)

Drug

Apixaban at a dose of 2.5 or 5 mg twice daily

Other names: Non-Vitamin K Oral Anticoagulant (NOAC)

Warfarin

Drug

Warfarin dose as prescribed by medical practitioner

Other names: Vitamin K Antagonist

Primary outcomes

  1. 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.

  2. Risk of ischemic events

    Time frame: Retrospective analysis of data from 2012 to 2017

    Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.

Secondary outcomes

  1. Risk of intracranial hemorrhage in NVAF-patients with renal impairment

    Time frame: Retrospective analysis of data from 2012 to 2017

    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.

  2. Risk of ischemic events in NVAF-patients with renal impairment

    Time frame: Retrospective analysis of data from 2012 to 2017

    Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.

  3. Risk of intracranial hemorrhage in NVAF-patients with diabetes

    Time frame: Retrospective analysis of data from 2012 to 2017

    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.

  4. Risk of ischemic events in NVAF-patients with diabetes

    Time frame: Retrospective analysis of data from 2012 to 2017

    Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.

  5. All-cause mortality

    Time frame: Retrospective analysis of data from 2012 to 2017

    Rate of deaths from all causes.

  6. Drug utilisation

    Time frame: Retrospective analysis of data from 2012 to 2017

    Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.

  7. Drug utilisation after first intracranial hemorrhage or ischemic stroke

    Time frame: Retrospective analysis of data from 2012 to 2017

    Drug utilisation comprises a descriptive analysis of characteristics of index prescription, time trends and drug discontinuation.

  8. Patient characteristics

    Time frame: Retrospective analysis of data from 2012 to 2017

    Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.

  9. Patient characteristics after first intracranial hemorrhage or ischemic stroke

    Time frame: Retrospective analysis of data from 2012 to 2017

    Patient characteristics comprise a descriptive analysis of baseline characteristics, comorbidities, co-medications and time trends.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen, LP

Registry information

Official study 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

Acronym: SiERRA UK

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.