Evaluation of Safety and Effectiveness on Oral Anticoagulants

Bristol-Myers Squibb12,354 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

12,354

Conditions

Atrial Fibrillation

Interventions

Non-InterventionalOTHER

Non-Interventional

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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-2016. 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

Locations (1)

Local Institution

Minato-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Incidence of major bleeding among oral anticoagulant (OAC) initiators

Time frame: Maximum 3 years

Secondary Outcomes

Incidence of thromboembolic events

Time frame: Maximum 3 years

Incidence of stoke/SE (secondary event) among OAC initiators

Time frame: Maximum 3 years

Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr

CCr creatinine clearance (\< 50ml/min and \> 50ml/min)

Time frame: Maximum 3 years

Incidence of cardiovascular/all cause death among OAC initiators

Time frame: Maximum 3 years

Incidence of myocardial infarction among OAC initiators

Time frame: Maximum 3 years

Incidence of major adverse cardiac event among OAC initiators

Time frame: Maximum 3 years

Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)

CCr (\< 50ml/min and \> 50ml/min)

Time frame: Maximum 3 years

Incidence of myocardial infarction among OAC initiators stratified by CCr

CCr (\< 50ml/min and \> 50ml/min)

Time frame: Maximum 3 years

Incidence of major adverse cardiac event among OAC initiators stratified by CCr

Data from ClinicalTrials.gov

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