Non-valvular Atrial FibrillationNCT03508258
Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)
An observational study of Non-valvular Atrial Fibrillation, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- Non-interventional
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Sep 2018
- 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: NVAF patients newly prescribed NOACs in England
Who may be able to join
- Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment)
- Incident prescription of an oral anticoagulant (index date)
- Patients with at least one year of computerized data prior to index date
Who cannot join
- Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes
- Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England
Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Non-interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Participants with NVAF starting Apixaban | Not described Receives: Other: Non-interventional | |
| Participants with NVAF starting Warfarin | 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
Measured: At the end of 1 year
Incidence of intracranial bleeding
Measured: At the end of 1 year
Incidence of gastrointestinal bleeding
Measured: At the end of 1 year
Incidence of clinically relevant non-major bleeding
Measured: At the end of 1 year
Incidence of ischemic stroke
Measured: At the end of 1 year
Incidence of unspecified stroke
Measured: At the end of 1 year
Incidence of systemic embolic events
Measured: At the end of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start1 Sep 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Why it stopped: Study was discontinued in 2018 as sufficient sample size was not met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular 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
- 0 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
- NCT03508258
- Sponsor's protocol ID
- CV185-664
- Status last verified
- Jun 2022
- First submitted
- 16 Apr 2018
- Last updated
- 30 Jun 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England
- ClinicalTrials.gov ID
- NCT03508258
- Acronym / sponsor ID
- CV185-664
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was discontinued in 2018 as sufficient sample size was not met.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 25 Apr 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.
Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with NVAF starting Apixaban | – | Other: Non-interventional |
| Participants with NVAF starting Warfarin | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NVAF patients newly prescribed NOACs in England
Key inclusion criteria (3 listed)
- Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment)
- Incident prescription of an oral anticoagulant (index date)
- Patients with at least one year of computerized data prior to index date
Key exclusion criteria (3 listed)
- Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes
- Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index
- 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 | Participants with NVAF starting Apixaban |
| Non-InterventionalNon-Interventional | Other | Participants with NVAF starting Warfarin |
Primary outcome
Incidence of major bleeding
Time frame: At the end of 1 year
Incidence of intracranial bleeding
Time frame: At the end of 1 year
Incidence of gastrointestinal bleeding
Time frame: At the end of 1 year
Incidence of clinically relevant non-major bleeding
Time frame: At the end of 1 year
Incidence of ischemic stroke
Time frame: At the end of 1 year
Incidence of unspecified stroke
Time frame: At the end of 1 year
Incidence of systemic embolic events
Time frame: At the end of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 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, run by Bristol-Myers Squibb at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 30 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: At the end of 1 year). The study lists 7 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 30 Jun 2022.