NCT04099238

Brief Summary

This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a UK general population using The Health Improvement Network (THIN) database. The main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received OAC at the time of the stroke. In addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue OAC treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,739

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

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

September 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2020

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

September 20, 2019

Last Update Submit

April 23, 2021

Conditions

Atrial Fibrillation

Keywords

Ischemic strokeNon-valvular atrial fibrillation (NVAF)Oral anticoagulants (OAC)Vitamin K antagonists (NKA)Non-vitamin K antagonist oral anticoagulants (NOAC)Discontinuation

Outcome Measures

Primary Outcomes (14)

  • Number of subjects with ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018

  • Incidence of ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018

  • Number of NVAF patients with OAC prescription prior to ischemic stroke

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Duration of OAC treatment before OAC discontinuation for NVAF patients

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Time period from OAC discontinuation to ischemic stroke for NVAF patients

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke after OAC discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke by time since OAC discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke by OAC treatment duration before OAC discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke after VKA discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke by time since VKA discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke by VKA treatment duration before VKA discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke after NOAC discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke by time since NOAC discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

  • Relative risk of NVAF patients for ischemic stroke by NOAC treatment duration before NOAC discontinuation

    For NVAF subgroup only

    Retrospective analysis of data from 01-Jul-1996 to 30-Jun-2018

Secondary Outcomes (13)

  • Number of subjects with first diagnosis of NVAF at time of ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2018

  • Number of subjects with first diagnosis of NVAF within 1 month after ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jul-2018

  • Number of subjects with first diagnosis of NVAF within 12 months after ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  • Prevalence of cardiovascular co-morbidities one year before ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  • Prevalence of cardiovascular co-morbidities 12 months after ischemic stroke

    Retrospective analysis of data from 01-Jul-2016 to 30-Jun-2019

  • +8 more secondary outcomes

Study Arms (2)

Subjects with ischemic stroke

Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018

Drug: Oral anticoagulant

NVAF patients with ischemic stroke

Adult subjects from the UK THIN database who were hospitalized for ischemic stroke between 01-Jul-2016 to 30-Jun-2018 and had a diagnosis of NVAF prior to ischemic stroke (Subgroup)

Drug: Oral anticoagulant

Interventions

Oral anticoagulantDRUG

Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).

Also known as: Warfarin, acenocoumarol, phenindione, apixaban, dabigatran, edoxaban, rivaroxaban
NVAF patients with ischemic strokeSubjects with ischemic stroke

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults from UK with electronic medical records in The Health Improvement Network (THIN) database

You may qualify if:

  • Occurrence of an ischemic stroke that lead to hospitalization between 01-Jul-2016 to 30-Jun-2018 and concerned adults registered in the THIN database
  • Subgroup: Patients with diagnosed NVAF prior or at the time of ischemic stroke

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many facilities

Multiple Locations, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Atrial FibrillationIschemic Stroke

Interventions

AnticoagulantsWarfarinAcenocoumarolPhenindioneapixabanDabigatranedoxabanRivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPyridinesBenzimidazolesThiophenesSulfur CompoundsMorpholinesOxazines

Study Design

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

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 23, 2019

Study Start

October 1, 2019

Primary Completion

July 16, 2020

Study Completion

July 16, 2020

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

GB(1)