check_circleStudy Completed

Atrial fibrillation

Bayer Identifier:

20343

ClinicalTrials.gov Identifier:

NCT03847181

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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

  • - 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 summary

Enrollment Goal
45164
Trial Dates
February 2019 - October 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, United Kingdom

Primary Outcome

  • Risk of intracranial hemorrhage
    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
    date_rangeTime Frame:
    Retrospective analysis of data from 2012 to 2017
  • Risk of ischemic events
    Ischemic events include ischaemic stroke / systemic embolism and myocardial infarction.
    date_rangeTime Frame:
    Retrospective analysis of data from 2012 to 2017

Secondary Outcome

  • Risk of intracranial hemorrhage in NVAF-patients with renal impairment
    Intracranial hemorrhage includes intracerebral hemorrhage, subarachnoid hemorrhage, subdural and epidural hemorrhage.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective analysis of data from 2012 to 2017
  • All-cause mortality
    Rate of deaths from all causes.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Retrospective analysis of data from 2012 to 2017

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
N/A