Clinical trial NCT05027061: A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan
Official title: Retrospective Medical Chart Review Study for Non-valvular Atrial Fibrillation Patients Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Valvular Atrial Fibrillation (NVAF)
Keywords: BMS-562247
Apixaban
Atrial fibrillation
Oral Anticoagulants
Japan
Retrospective Study
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 11776
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of an estimated 12,000 Non-valvular atrial fibrillation (NVAF) participants' medical charts that will fulfill the study eligibility criteria.

Brief summary: The purpose of this observational study is to understand real-world oral anticoagulants (OAC) (warfarin, apixaban, dabigatran, edoxaban and rivaroxaban) usage for non-valvular atrial fibrillation (NVAF) patients.


Eligibility criteria: Inclusion Criteria:

• Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.

Exclusion Criteria:

* Had no data of serum creatinine in the participant's medical records
* Had no data of body weight in the participant's medical records
* Were given oral anticoagulant (OAC) for treatment of diseases other than atrial fibrillation (AF)

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Specialization of the treating physician
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of NVAF participants: Age group
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of NVAF participants: Gender
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of NVAF participants: Body weight
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of NVAF participants: Height
timeFrame: At Baseline
measure: Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Drinking information
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Smoking information
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Internal medical device information
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Degree of life freedom
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Hospitalization/outpatient status
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: Pulse rate
timeFrame: At Baseline
measure: Distribution of clinical characteristics of NVAF participants: Risk factors for stroke
timeFrame: At Baseline
measure: Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding
timeFrame: At Baseline
measure: Distribution of clinical characteristics of NVAF participants: Comorbidities
timeFrame: At Baseline
measure: Distribution of outcomes of NVAF participants: OAC prescription and administration status
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: calcium antagonist
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: Antiarrhythmic drug
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: Statin
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: H2-receptor antagonist
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: aspirin
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: P2Y12 inhibitor
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: Other antiplatelet drugs
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: Other anticoagulants
timeFrame: At Baseline
measure: Distribution of medication prescribed during baseline: P-glycoprotein inhibitor
timeFrame: At Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: