Atrial FibrillationRCR-OACNCT03765242
Evaluation of Safety and Effectiveness on Oral Anticoagulants
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Non-Interventional
- How many people
- 12,354 participants
- Where
- 1 siteJapan
- Study dates
- 21 Sep 2018to 25 Dec 2020
- 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: Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria
Who may be able to join
- Individuals greater than or equal to 20 years old as of the index date
- At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
- Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date
Who cannot join
- Patient's medical records indicating pregnancy during the follow-up period
- Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
- Had > 1 OAC prescription in the patient's medical records on the index date
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
- Conditions
- Atrial Fibrillation
- Being tested
- Non-Interventional
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Patient initiating warfarin | Not described Receives: Other: Non-Interventional | |
| Patient initiating apixaban | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major bleeding among oral anticoagulant (OAC) initiators
Measured: Maximum 3 years
Secondary outcomes (10)
Incidence of thromboembolic events
Measured: Maximum 3 years
Incidence of stoke/SE (secondary event) among OAC initiators
Measured: Maximum 3 years
Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr
CCr creatinine clearance (< 50ml/min and > 50ml/min)
Measured: Maximum 3 years
Incidence of cardiovascular/all cause death among OAC initiators
Measured: Maximum 3 years
Incidence of myocardial infarction among OAC initiators
Measured: Maximum 3 years
Incidence of major adverse cardiac event among OAC initiators
Measured: Maximum 3 years
Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)
CCr (< 50ml/min and > 50ml/min)
Measured: Maximum 3 years
Incidence of myocardial infarction among OAC initiators stratified by CCr
CCr (< 50ml/min and > 50ml/min)
Measured: Maximum 3 years
Incidence of major adverse cardiac event among OAC initiators stratified by CCr
CCr (< 50ml/min and > 50ml/min)
Measured: Maximum 3 years
Distribution of clinical characteristics among OAC initiators
Clinical characteristics will be summarized using descriptive statistics
Measured: Maximum 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start21 Sep 2018
- Primary completion25 Dec 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- 12,354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765242
- Sponsor's protocol ID
- CV185-698
- Acronym
- RCR-OAC
- Status last verified
- May 2022
- First submitted
- 26 Nov 2018
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morimoto T, Hoshino H, Matsuo Y, Ibuki T, Miyata K, Koretsune Y. Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study. Am J Cardiovasc Drugs. 2023 Nov;23(6):721-733. doi: 10.1007/s40256-023-00611-7. Epub 2023 Oct 17.
PubMed 37847442
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant
- ClinicalTrials.gov ID
- NCT03765242
- Acronym / sponsor ID
- RCR-OAC / CV185-698
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,354 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 5 Dec 2018 (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.
This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient initiating warfarin | – | Other: Non-Interventional |
| Patient initiating apixaban | – | Other: Non-Interventional |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria
Key inclusion criteria (3 listed)
- Individuals greater than or equal to 20 years old as of the index date
- At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
- Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date
Key exclusion criteria (4 listed)
- Patient's medical records indicating pregnancy during the follow-up period
- Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
- Had > 1 OAC prescription in the patient's medical records on the index date
- Other protocol defined inclusion/exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Patient initiating apixaban, Patient initiating warfarin |
Primary outcome
Incidence of major bleeding among oral anticoagulant (OAC) initiators
Time frame: Maximum 3 years
10 secondary outcomes
Incidence of thromboembolic events
Time frame: Maximum 3 years
Incidence of stoke/SE (secondary event) among OAC initiators
Time frame: Maximum 3 years
Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr
Time frame: Maximum 3 years
Incidence of cardiovascular/all cause death among OAC initiators
Time frame: Maximum 3 years
Incidence of myocardial infarction among OAC initiators
Time frame: Maximum 3 years
Incidence of major adverse cardiac event among OAC initiators
Time frame: Maximum 3 years
Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)
Time frame: Maximum 3 years
Incidence of myocardial infarction among OAC initiators stratified by CCr
Time frame: Maximum 3 years
Incidence of major adverse cardiac event among OAC initiators stratified by CCr
Time frame: Maximum 3 years
Distribution of clinical characteristics among OAC initiators
Time frame: Maximum 3 years
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 13 May 2022.
- Derived from this study: PubMed 37847442Morimoto T, Hoshino H, Matsuo Y, Ibuki T, Miyata K, Koretsune Y. Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study. Am J Cardiovasc Drugs. 2023 Nov;23(6):721-733. doi: 10.1007/s40256-023-00611-7. Epub 2023 Oct 17.
- 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 Atrial Fibrillation, 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 3 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 13 May 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?
Incidence of major bleeding among oral anticoagulant (OAC) initiators (time frame: Maximum 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765242, which also lists 1 linked publication.
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 13 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.