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Clinical Trials/NCT05027061
NCT05027061
Completed
Not Applicable

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

Bristol-Myers Squibb1 site in 1 country11,776 target enrollmentApril 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-Valvular Atrial Fibrillation (NVAF)
Sponsor
Bristol-Myers Squibb
Enrollment
11776
Locations
1
Primary Endpoint
Distribution of outcomes of NVAF participants: Smoking information
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2021
End Date
December 4, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Distribution of outcomes of NVAF participants: Smoking information

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: Pulse rate

Time Frame: At Baseline

Distribution of socio-demographic characteristics of NVAF participants: Age group

Time Frame: At Baseline

Distribution of socio-demographic characteristics of NVAF participants: Height

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: Degree of life freedom

Time Frame: At Baseline

Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding

Time Frame: At Baseline

Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)

Time Frame: At Baseline

Distribution of medication prescribed during baseline: Antiarrhythmic drug

Time Frame: At Baseline

Distribution of medication prescribed during baseline: H2-receptor antagonist

Time Frame: At Baseline

Distribution of clinical characteristics of NVAF participants: Comorbidities

Time Frame: At Baseline

Specialization of the treating physician

Time Frame: At Baseline

Distribution of socio-demographic characteristics of NVAF participants: Gender

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure

Time Frame: At Baseline

Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: Hospitalization/outpatient status

Time Frame: At Baseline

Distribution of socio-demographic characteristics of NVAF participants: Body weight

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: Drinking information

Time Frame: At Baseline

Distribution of clinical characteristics of NVAF participants: Risk factors for stroke

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: OAC prescription and administration status

Time Frame: At Baseline

Distribution of medication prescribed during baseline: Statin

Time Frame: At Baseline

Distribution of medication prescribed during baseline: P2Y12 inhibitor

Time Frame: At Baseline

Distribution of medication prescribed during baseline: Other antiplatelet drugs

Time Frame: At Baseline

Distribution of medication prescribed during baseline: Other anticoagulants

Time Frame: At Baseline

Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)

Time Frame: At Baseline

Distribution of outcomes of NVAF participants: Internal medical device information

Time Frame: At Baseline

Distribution of medication prescribed during baseline: calcium antagonist

Time Frame: At Baseline

Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)

Time Frame: At Baseline

Distribution of medication prescribed during baseline: aspirin

Time Frame: At Baseline

Distribution of medication prescribed during baseline: P-glycoprotein inhibitor

Time Frame: At Baseline

Study Sites (1)

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