Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)

Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03508258

Enrollment

Registered

2018-04-25

Start date

2017-09-01

Completion date

2018-09-01

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-valvular Atrial Fibrillation

Brief summary

Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England

Interventions

OTHERNon-interventional

Non-interventional

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment) * Incident prescription of an oral anticoagulant (index date) * Patients with at least one year of computerized data prior to index date

Exclusion criteria

* Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes * Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Incidence of major bleeding	At the end of 1 year
Incidence of intracranial bleeding	At the end of 1 year
Incidence of gastrointestinal bleeding	At the end of 1 year
Incidence of clinically relevant non-major bleeding	At the end of 1 year
Incidence of ischemic stroke	At the end of 1 year
Incidence of unspecified stroke	At the end of 1 year
Incidence of systemic embolic events	At the end of 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026