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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05027061
Enrollment
11776
Registered
2021-08-30
Start date
2021-04-02
Completion date
2021-12-04
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Valvular Atrial Fibrillation (NVAF)

Keywords

BMS-562247, Apixaban, Atrial fibrillation, Oral Anticoagulants, Japan, Retrospective Study

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.

Interventions

None listed

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Specialization of the treating physicianAt Baseline
Distribution of socio-demographic characteristics of NVAF participants: Age groupAt Baseline
Distribution of socio-demographic characteristics of NVAF participants: GenderAt Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body weightAt Baseline
Distribution of socio-demographic characteristics of NVAF participants: HeightAt Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)At Baseline
Distribution of outcomes of NVAF participants: Drinking informationAt Baseline
Distribution of outcomes of NVAF participants: Smoking informationAt Baseline
Distribution of outcomes of NVAF participants: Internal medical device informationAt Baseline
Distribution of outcomes of NVAF participants: Degree of life freedomAt Baseline
Distribution of outcomes of NVAF participants: Hospitalization/outpatient statusAt Baseline
Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressureAt Baseline
Distribution of outcomes of NVAF participants: Pulse rateAt Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for strokeAt Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for bleedingAt Baseline
Distribution of clinical characteristics of NVAF participants: ComorbiditiesAt Baseline
Distribution of outcomes of NVAF participants: OAC prescription and administration statusAt Baseline
Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)At Baseline
Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)At Baseline
Distribution of medication prescribed during baseline: calcium antagonistAt Baseline
Distribution of medication prescribed during baseline: Antiarrhythmic drugAt Baseline
Distribution of medication prescribed during baseline: StatinAt Baseline
Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)At Baseline
Distribution of medication prescribed during baseline: H2-receptor antagonistAt Baseline
Distribution of medication prescribed during baseline: aspirinAt Baseline
Distribution of medication prescribed during baseline: P2Y12 inhibitorAt Baseline
Distribution of medication prescribed during baseline: Other antiplatelet drugsAt Baseline
Distribution of medication prescribed during baseline: Other anticoagulantsAt Baseline
Distribution of medication prescribed during baseline: P-glycoprotein inhibitorAt Baseline

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026