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

Bristol-Myers Squibb1 site in 1 countryStarted: September 1, 2017Last updated: June 30, 2022

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Withdrawn
Sponsor
Locations: 1
Primary Endpoint: Incidence of gastrointestinal bleeding

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Retrospective

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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/exclusion criteria could apply