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

Withdrawn

• Conditions: Non-valvular Atrial Fibrillation

• Registration Number: NCT03508258
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major bleeding	At the end of 1 year
Incidence of intracranial 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 clinically relevant non-major bleeding	At the end of 1 year
Incidence of systemic embolic events	At the end of 1 year
Incidence of gastrointestinal bleeding	At the end of 1 year

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Bethesda, Maryland, United States