Non-Valvular Atrial Fibrillation (NVAF)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
An observational study of Non-Valvular Atrial Fibrillation (NVAF), run by Bristol-Myers Squibb at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-Valvular Atrial Fibrillation (NVAF)
- Type of treatment
- Pill or oral medicine
- How many people
- 11,776 participants
- Where
- 1 siteJapan
- Study dates
- 2 Apr 2021to 4 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Non-Valvular Atrial Fibrillation (NVAF)
- Keywords
- BMS-562247, Apixaban, Atrial fibrillation, Oral Anticoagulants, Japan, Retrospective Study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Specialization of the treating physician
Measured: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Age group
Measured: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Gender
Measured: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body weight
Measured: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Height
Measured: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)
Measured: At Baseline
Distribution of outcomes of NVAF participants: Drinking information
Measured: At Baseline
Distribution of outcomes of NVAF participants: Smoking information
Measured: At Baseline
Distribution of outcomes of NVAF participants: Internal medical device information
Measured: At Baseline
Distribution of outcomes of NVAF participants: Degree of life freedom
Measured: At Baseline
Distribution of outcomes of NVAF participants: Hospitalization/outpatient status
Measured: At Baseline
Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure
Measured: At Baseline
Distribution of outcomes of NVAF participants: Pulse rate
Measured: At Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for stroke
Measured: At Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding
Measured: At Baseline
Distribution of clinical characteristics of NVAF participants: Comorbidities
Measured: At Baseline
Distribution of outcomes of NVAF participants: OAC prescription and administration status
Measured: At Baseline
Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)
Measured: At Baseline
Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)
Measured: At Baseline
Distribution of medication prescribed during baseline: calcium antagonist
Measured: At Baseline
Distribution of medication prescribed during baseline: Antiarrhythmic drug
Measured: At Baseline
Distribution of medication prescribed during baseline: Statin
Measured: At Baseline
Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)
Measured: At Baseline
Distribution of medication prescribed during baseline: H2-receptor antagonist
Measured: At Baseline
Distribution of medication prescribed during baseline: aspirin
Measured: At Baseline
Distribution of medication prescribed during baseline: P2Y12 inhibitor
Measured: At Baseline
Distribution of medication prescribed during baseline: Other antiplatelet drugs
Measured: At Baseline
Distribution of medication prescribed during baseline: Other anticoagulants
Measured: At Baseline
Distribution of medication prescribed during baseline: P-glycoprotein inhibitor
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start2 Apr 2021
- Primary completion4 Dec 2021
- Study completion4 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Valvular Atrial Fibrillation (NVAF)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027061
- Sponsor's protocol ID
- CV185-771
- Status last verified
- Feb 2022
- First submitted
- 26 Aug 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05027061
- Acronym / sponsor ID
- CV185-771
- Conditions
- Non-Valvular Atrial Fibrillation (NVAF)
- Keywords
- BMS-562247, Apixaban, Atrial fibrillation, Oral Anticoagulants, Japan, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,776 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 4 Dec 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specialization of the treating physician
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: Gender
Time frame: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Body weight
Time frame: At Baseline
Distribution of socio-demographic characteristics of NVAF participants: Height
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: Drinking information
Time frame: At Baseline
Distribution of outcomes of NVAF participants: Smoking information
Time frame: At Baseline
Distribution of outcomes of NVAF participants: Internal medical device information
Time frame: At Baseline
Distribution of outcomes of NVAF participants: Degree of life freedom
Time frame: At Baseline
Distribution of outcomes of NVAF participants: Hospitalization/outpatient status
Time frame: At Baseline
Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure
Time frame: At Baseline
Distribution of outcomes of NVAF participants: Pulse rate
Time frame: At Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for stroke
Time frame: At Baseline
Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding
Time frame: At Baseline
Distribution of clinical characteristics of NVAF participants: Comorbidities
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: angiotensin-converting enzyme inhibitor (ACE)
Time frame: At Baseline
Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)
Time frame: At Baseline
Distribution of medication prescribed during baseline: calcium antagonist
Time frame: At Baseline
Distribution of medication prescribed during baseline: Antiarrhythmic drug
Time frame: At Baseline
Distribution of medication prescribed during baseline: Statin
Time frame: At Baseline
Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)
Time frame: At Baseline
Distribution of medication prescribed during baseline: H2-receptor antagonist
Time frame: At Baseline
Distribution of medication prescribed during baseline: aspirin
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 medication prescribed during baseline: P-glycoprotein inhibitor
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Valvular Atrial Fibrillation (NVAF), run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specialization of the treating physician (time frame: At Baseline). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.