Atrial FibrillationNCT02661516
Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-valvular Atrial Fibrillation Treated With Vitamin k Antagonists
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb.
Trial summary
The purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 16,513 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective cohort with study period from January 1, 2003 to December 31, 2013 using the Clinical Practice Research Datalink (CPRD). The study will identify AF patients treated with VKA during the study period and will follow them from the first record of VKA use (index date). until the first of end of study period, leaving the database, VKA discontinuation/switch, or death. It will use person-time denominators to handle the varying length of follow-up of patients
Who may be able to join
- For the CPRD-HES cohort, patients will be included if they meet these criteria:
- Have CPRD data linked to HES
- Have an AF diagnosis (based on Read codes from CPRD or ICD-10 codes from HES) and have been treated with VKA during the study period
- -≥18 years old at index date
- CPRD acceptability quality criteria are present.
- For the CPRD cohort, patients will be included if they meet the following criteria:
Show all 9Show fewer
- Have an Atrial Fibrillation (AF) diagnosis (based on Read codes from CPRD) and have been treated with VKAs during the study period
- ≥18 years old at index date
- CPRD acceptability quality criteria are present.
Who cannot join
- For the two cohorts of interest, patients will be excluded if they meet the following criteria:
- Fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). The date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's Up-to-Standard (UTS) date (when the practice is deemed to be contributing data of adequate quality)
- The practice is not UTS, or the patient is deemed "unacceptable" according to CPRD's quality criteria
- There is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period
- There are records of Novel anticoagulant (NOAC)
About this study
Official title: Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-Valvular Atrial Fibrillation Treated With Vitamin K Antagonists
The purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).
- Conditions
- Atrial Fibrillation
- 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 |
|---|---|---|
| Vitamin K Antagonists | Vitamin K Antagonists dose as specified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios
Measured: Up to 24 months after initial treatment with VKA
Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios
Measured: Up to 24 months after initial treatment with VKA
Impact of bleeding events on the health-care costs in NVAF patients treated by VKAs assessed based on ratios of costs associated with number of bleeding events
Measured: Up to 24 months after initial treatment with VKA
Secondary outcomes (3)
Variation of impact of bleeding events on clinical events, the rate of HCRU, and health-care costs over time following each bleeding event in NVAF patients treated by VKA
Measured: Upto 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who experience bleeding events
Measured: Up to 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events
Measured: Up to 24 months after initial treatment with VKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 16,513 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
- NCT02661516
- Sponsor's protocol ID
- CV185-338
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2016
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-Valvular Atrial Fibrillation Treated With Vitamin K Antagonists
- ClinicalTrials.gov ID
- NCT02661516
- Acronym / sponsor ID
- CV185-338
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,513 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jan 2016 (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 purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin K Antagonists | – | –Vitamin K Antagonists dose as specified |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective cohort with study period from January 1, 2003 to December 31, 2013 using the Clinical Practice Research Datalink (CPRD). The study will identify AF patients treated with VKA during the study period and will follow them from the first record of VKA use (index date). until the first of end of study period, leaving the database, VKA discontinuation/switch, or death. It will use person-time denominators to handle the varying length of follow-up of patients
Key inclusion criteria (9 listed)
- Have CPRD data linked to HES
- Have an AF diagnosis (based on Read codes from CPRD or ICD-10 codes from HES) and have been treated with VKA during the study period
- -≥18 years old at index date
- CPRD acceptability quality criteria are present.
- Have an Atrial Fibrillation (AF) diagnosis (based on Read codes from CPRD) and have been treated with VKAs during the study period
Key exclusion criteria (5 listed)
- For the two cohorts of interest, patients will be excluded if they meet the following criteria:
- Fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). The date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's Up-to-Standard (UTS) date (when the practice is deemed to be contributing data of adequate quality)
- The practice is not UTS, or the patient is deemed "unacceptable" according to CPRD's quality criteria
- There is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period
- There are records of Novel anticoagulant (NOAC)
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
Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios
Time frame: Up to 24 months after initial treatment with VKA
Impact of bleeding events on the rate of health-care resource utilization (HCRU) assessed based on incidence rate ratios
Time frame: Up to 24 months after initial treatment with VKA
Impact of bleeding events on the health-care costs in NVAF patients treated by VKAs assessed based on ratios of costs associated with number of bleeding events
Time frame: Up to 24 months after initial treatment with VKA
3 secondary outcomes
Variation of impact of bleeding events on clinical events, the rate of HCRU, and health-care costs over time following each bleeding event in NVAF patients treated by VKA
Time frame: Upto 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who experience bleeding events
Time frame: Up to 24 months after initial treatment with VKA
Characteristics of NVAF patients newly treated with VKA who do not experience bleeding events
Time frame: Up to 24 months after initial treatment with VKA
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 22 Jan 2016.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb.
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 9 inclusion and 5 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Impact of bleeding events on the risk of subsequent clinical events including subsequent bleeds assessed based on hazard ratios (time frame: Up to 24 months after initial treatment with VKA). The study lists 3 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 22 Jan 2016.