Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant

Bristol-Myers Squibb1 site in 1 country12,354 target enrollmentSeptember 21, 2018

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Bristol-Myers Squibb
Enrollment: 12354
Locations: 1
Primary Endpoint: Incidence of major bleeding among oral anticoagulant (OAC) initiators
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment

Registry

clinicaltrials.gov

Start Date

September 21, 2018

End Date

December 25, 2020

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals greater than or equal to 20 years old as of the index date
•At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
•Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-
•The first warfarin or apixaban prescription date during the identification period will be designated as the index date

Exclusion Criteria

•Patient's medical records indicating pregnancy during the follow-up period
•Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
•Had \> 1 OAC prescription in the patient's medical records on the index date
•Other protocol defined inclusion/exclusion criteria could apply

Outcomes

Primary Outcomes

Incidence of major bleeding among oral anticoagulant (OAC) initiators

Time Frame: Maximum 3 years

Secondary Outcomes

Incidence of stoke/SE (secondary event) among OAC initiators(Maximum 3 years)
Incidence of major adverse cardiac event among OAC initiators(Maximum 3 years)
Incidence of major adverse cardiac event among OAC initiators stratified by CCr(Maximum 3 years)
Incidence of cardiovascular/all cause death among OAC initiators(Maximum 3 years)
Incidence of myocardial infarction among OAC initiators(Maximum 3 years)
Incidence of myocardial infarction among OAC initiators stratified by CCr(Maximum 3 years)
Distribution of clinical characteristics among OAC initiators(Maximum 3 years)
Incidence of thromboembolic events(Maximum 3 years)
Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr(Maximum 3 years)
Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)(Maximum 3 years)