NonValvular Atrial FibrillationNCT02007655
Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
An observational study of NonValvular Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The primary objectives of this study are: To estimate the incidence rate of unexpected adverse events To characterize the bleeding events and assess risk factors of bleeding To identify ancillary baseline variables that may also be associated with adverse outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NonValvular Atrial Fibrillation
- What is being tested?
- Eliquis
- How many people
- 6,372 participants
- Where
- 1 siteJapan
- Study dates
- 1 Sep 2013to 31 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed
Who may be able to join
- Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study
Who cannot join
- Patients who are receiving Eliquis outside of its approved indication will be excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of this study are:
- To estimate the incidence rate of unexpected adverse events
- To characterize the bleeding events and assess risk factors of bleeding
- To identify ancillary baseline variables that may also be associated with adverse outcomes
- Conditions
- NonValvular Atrial Fibrillation
- Being tested
- Eliquis
- Keywords
- Cardiovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EliquisDrug
Also called Apixaban, BMS-562247
| Study group | Role | What they receive |
|---|---|---|
| Eliquis on Nonvalvular Atrial Fibrilliation patients | Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study Receives: Drug: Eliquis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of unexpected adverse events
Measured: Day 1 (At Eliquis initiation)
Incidence rate of unexpected adverse events
Measured: 12 weeks after initiation
Incidence rate of unexpected adverse events
Measured: 52 weeks after initiation
Incidence rate of unexpected adverse events
Measured: 104 week (discontinuation)
Bleeding events and risk factors of bleeding
Measured: Day 1 (At Eliquis initiation)
Bleeding events and risk factors of bleeding
Measured: 12 weeks after initiation
Bleeding events and risk factors of bleeding
Measured: 52 weeks after initiation
Bleeding events and risk factors of bleeding
Measured: 104 week (discontinuation)
Ancillary baseline variables that may also be associated with adverse outcomes
Measured: Day 1 (At Eliquis initiation)
Ancillary baseline variables that may also be associated with adverse outcomes
Measured: 12 weeks after initiation
Ancillary baseline variables that may also be associated with adverse outcomes
Measured: 52 weeks after initiation
Ancillary baseline variables that may also be associated with adverse outcomes
Measured: 104 week (discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start1 Sep 2013
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
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 NonValvular 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,372 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
- NCT02007655
- Sponsor's protocol ID
- CV185-286
- Status last verified
- Jun 2022
- First submitted
- 6 Dec 2013
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M. Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study. J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15.
PubMed 31421933
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02007655
- Acronym / sponsor ID
- CV185-286
- Conditions
- NonValvular Atrial Fibrillation
- Keywords
- Cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,372 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 11 Dec 2013 (estimated)
- 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 primary objectives of this study are:
- To estimate the incidence rate of unexpected adverse events
- To characterize the bleeding events and assess risk factors of bleeding
- To identify ancillary baseline variables that may also be associated with adverse outcomes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eliquis on Nonvalvular Atrial Fibrilliation patients | – | Drug: EliquisPatients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University hospitals, general hospitals, and clinics that have relevant departments, such as cardiology, cerebrovascular medicine, neurology, internal medicine, neurosurgery, etc, where the surveillance drug is mainly prescribed
Key inclusion criteria (1 listed)
- Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study
Key exclusion criteria (1 listed)
- Patients who are receiving Eliquis outside of its approved indication will be excluded from this study
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 |
|---|---|---|
| EliquisAlso: Apixaban, BMS-562247 | Drug | Eliquis on Nonvalvular Atrial Fibrilliation patients |
Primary outcome
Incidence rate of unexpected adverse events
Time frame: Day 1 (At Eliquis initiation)
Incidence rate of unexpected adverse events
Time frame: 12 weeks after initiation
Incidence rate of unexpected adverse events
Time frame: 52 weeks after initiation
Incidence rate of unexpected adverse events
Time frame: 104 week (discontinuation)
Bleeding events and risk factors of bleeding
Time frame: Day 1 (At Eliquis initiation)
Bleeding events and risk factors of bleeding
Time frame: 12 weeks after initiation
Bleeding events and risk factors of bleeding
Time frame: 52 weeks after initiation
Bleeding events and risk factors of bleeding
Time frame: 104 week (discontinuation)
Ancillary baseline variables that may also be associated with adverse outcomes
Time frame: Day 1 (At Eliquis initiation)
Ancillary baseline variables that may also be associated with adverse outcomes
Time frame: 12 weeks after initiation
Ancillary baseline variables that may also be associated with adverse outcomes
Time frame: 52 weeks after initiation
Ancillary baseline variables that may also be associated with adverse outcomes
Time frame: 104 week (discontinuation)
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 7 Jun 2022.
- Derived from this study: PubMed 31421933Inoue H, Umeyama M, Yamada T, Hashimoto H, Komoto A, Yasaka M. Safety and effectiveness of reduced-dose apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A sub-analysis of the STANDARD study. J Cardiol. 2020 Feb;75(2):208-215. doi: 10.1016/j.jjcc.2019.07.007. Epub 2019 Aug 15.
- 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 NonValvular 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 1 inclusion and 1 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 7 Jun 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 rate of unexpected adverse events (time frame: Day 1 (At Eliquis initiation)). The study lists 12 primary outcomes in all. 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 NCT02007655, 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 7 Jun 2022.