NCT03847181

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45,164

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

1.7 years

First QC Date

February 18, 2019

Last Update Submit

October 27, 2021

Conditions

Atrial Fibrillation

Keywords

Oral anticoagulantsUnder-dosingStroke prevention in atrial fibrillationSafetyEffectiveness

Outcome Measures

Primary Outcomes (2)

  • Risk of intracranial hemorrhage

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

    Retrospective analysis of data from 2012 to 2017

  • Risk of ischemic events

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

    Retrospective analysis of data from 2012 to 2017

Secondary Outcomes (9)

  • Risk of intracranial hemorrhage in NVAF-patients with renal impairment

    Retrospective analysis of data from 2012 to 2017

  • Risk of ischemic events in NVAF-patients with renal impairment

    Retrospective analysis of data from 2012 to 2017

  • Risk of intracranial hemorrhage in NVAF-patients with diabetes

    Retrospective analysis of data from 2012 to 2017

  • Risk of ischemic events in NVAF-patients with diabetes

    Retrospective analysis of data from 2012 to 2017

  • All-cause mortality

    Retrospective analysis of data from 2012 to 2017

  • +4 more secondary outcomes

Study Arms (3)

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.

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.

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.

Drug: Warfarin

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Rivaroxaban at a dose of 15 or 20 mg once daily

Also known as: Non-Vitamin K Oral Anticoagulant (NOAC)
NVAF-patients_1
Apixaban (Eliquis)DRUG

Apixaban at a dose of 2.5 or 5 mg twice daily

Also known as: Non-Vitamin K Oral Anticoagulant (NOAC)
NVAF-patients_2
WarfarinDRUG

Warfarin dose as prescribed by medical practitioner

Also known as: Vitamin K Antagonist
NVAF-patients_3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UK population sample representative for age, sex and geographic distribution

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many facilities

Many Sites, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

RivaroxabanapixabanWarfarinacarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 20, 2019

Study Start

February 28, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

GB(1)