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NCT03508258 Clinical Trial

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

Non-valvular Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03508258
Other study ID # CV185-664
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2018

Study information
Verified date June 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Non-interventional
Non-interventional
• Non-Interventional
Non-Interventional

Locations
Country Name City State
United States Local Institution Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of major bleeding At the end of 1 year
Primary Incidence of intracranial bleeding At the end of 1 year
Primary Incidence of gastrointestinal bleeding At the end of 1 year
Primary Incidence of clinically relevant non-major bleeding At the end of 1 year
Primary Incidence of ischemic stroke At the end of 1 year
Primary Incidence of unspecified stroke At the end of 1 year
Primary Incidence of systemic embolic events At the end of 1 year
See also
  Status Clinical Trial Phase
Completed NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Terminated NCT03715725 - A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.
Active, not recruiting NCT05565599 - An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation N/A
Completed NCT02756481 - Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela N/A
Completed NCT04193826 - The Conformal Prague Study N/A
Completed NCT01884350 - Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) Phase 4
Completed NCT02422602 - Better Adherence With New Oral Anticoagulant in Atrial Fibrillation : Effectiveness of a Personalized Education Program N/A
Recruiting NCT02147444 - Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation N/A
Completed NCT01857622 - Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment Phase 3
Recruiting NCT04829929 - Evaluation od Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk N/A
Recruiting NCT05761704 - Exploratory Observation of Two Short-term Regimens After LAA Occlusion by LAMax LAAC® Device for Subjects With Non-valvular Atrial Fibrillation N/A
Recruiting NCT04559243 - Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
Completed NCT03570047 - Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
Terminated NCT03204695 - WAVECREST Post Market Clinical Follow-Up (PMCF) Study N/A
Completed NCT04722679 - A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.
Completed NCT04297072 - Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists
Recruiting NCT05320627 - Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation Phase 4
Recruiting NCT03088072 - A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure Phase 4
Completed NCT04519944 - Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention
Completed NCT02488421 - Real Evidence of Anticoagulation Treatment in Non-valvular Atrial Fibrillation in Germany, UK and France: REACT-AF2 N/A

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