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

March 3, 2022 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11776

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1070052
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cohort 1
Non-valvular atrial fibrillation (NVAF) participants receiving oral anticoagulant - Warfarin
Cohort 2
NVAF participants receiving oral anticoagulant - Apixaban
Cohort 3
NVAF participants receiving oral anticoagulant - Dabigatran
Cohort 4
NVAF participants receiving oral anticoagulant - Edoxaban
Cohort 5
NVAF participants receiving oral anticoagulant - Rivaroxaban
Cohort 6
NVAF participants not receiving oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specialization of the treating physician
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Age group
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Gender
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body weight
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Height
Time Frame: At Baseline
At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Drinking information
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Smoking information
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Internal medical device information
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Degree of life freedom
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Hospitalization/outpatient status
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: Pulse rate
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for stroke
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding
Time Frame: At Baseline
At Baseline
Distribution of clinical characteristics of NVAF participants: Comorbidities
Time Frame: At Baseline
At Baseline
Distribution of outcomes of NVAF participants: OAC prescription and administration status
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: calcium antagonist
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: Antiarrhythmic drug
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: Statin
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: H2-receptor antagonist
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: aspirin
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: P2Y12 inhibitor
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: Other antiplatelet drugs
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: Other anticoagulants
Time Frame: At Baseline
At Baseline
Distribution of medication prescribed during baseline: P-glycoprotein inhibitor
Time Frame: At Baseline
At Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2021

Primary Completion (Actual)

December 4, 2021

Study Completion (Actual)

December 4, 2021

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-771

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Valvular Atrial Fibrillation (NVAF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe