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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

NCT03847181 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45164

Last updated 2021-10-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban at a dose of 15 or 20 mg once daily

DRUG

Apixaban (Eliquis)

Apixaban at a dose of 2.5 or 5 mg twice daily

DRUG

Warfarin

Warfarin dose as prescribed by medical practitioner

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847181 on ClinicalTrials.gov