AnticoagulationNCT02492828
Adherence of Apixaban and Warfarin in Patients With Arterial Fibrillation in Real-world Setting in Sweden
An observational study of Anticoagulation, run by Bristol-Myers Squibb.
Trial summary
This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- How many people
- 41,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 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: The study will include all patients with filled prescriptions for apixaban or warfarin between May 29, 2013 and Dec 31, 2014 that are identified with a hospital diagnosis of non-valvular atrial fibrillation (NVAF)
Who may be able to join
- For the AF cohort
- Patients that have ≥1 AF diagnosis registered in the patient register
- Apixaban subcohort 1
- Patients eligible for the AF cohort
- Patients that had a first prescription for apixaban during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months
- Warfarin subcohort 1
Show all 11Show fewer
- Patients eligible for the AF cohort
- Patients that had a first prescription for warfarin during the identification period without previous prescriptions for NOACs or warfarin during the preceding 12 months
- Apixaban subcohort 2
- Patients eligible for the AF cohort
- Patients that had a first prescription for apixaban during
Who cannot join
- For the AF cohort:
- Patients with valvular AF will be excluded (see definition Appendix 1)
- Warfarin subcohort 1:
- Patients will be excluded from this sub-cohort if they had at least one prescription for warfarin or NOACs during the 12-month period preceding the first prescription for warfarin during the identification period, ie, the index date
About this study
Official title: Adherence of Apixaban and Warfarin in Patients With Atrial Fibrillation in Real-world Setting in Sweden
This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index date) until their death, exiting the database, or until the end of the study period (June 30, 2015).
- Conditions
- Anticoagulation
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 |
|---|---|---|
| Patients for filled prescriptions for apixaban | Not described | |
| Patients for filled prescriptions for warfarin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare adherence among Atrial Fibrillation (AF) patients initiating treatment with apixaban (without previous warfarin or novel anticoagulant (NOAC) use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)
Adherence: Adherence will be defined including missing doses and treatment discontinuation using the following approaches:
"Drug at disposal" approach: Based on information on prescribed dosing (mg/day) and information on filled prescriptions (mg expensed from the pharmacy); it is possible to calculate for how long a period the drug will last for that specific patient. Adherence is then defined using the Medication Possession Ratio (MPR) calculated as the ratio of number of days of treatment supply divided by the total length of follow-up time, and converted to a percentage (in the graph below illustrated as the sum of the grey horizontal bars divided by the length of follow-up, ie, time between index date and end of follow-up). The MPR will be computed as a continuous and binary variable (MPR>80%, ie, high vs low adherence)
Measured: approximately 6 to 12 months
Compare persistence among AF patients initiating treatment with apixaban (without previous warfarin or NOAC use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)
Persistence: Persistence will be defined as treatment discontinuation and will be measured by estimating the following:
- Time to discontinuation: Date of therapy cessation is not possible to determine with certainty due to the nature of registry data. In order to be able to estimate the time of discontinuation, patients will be considered on treatment for the full time between two purchases as long as they have at least one refill in a six month period. If there is no new purchase within six months the patient is considered to have terminated treatment at a date corresponding to how long the last prescription will last (in the graph below illustrated as the time between index date and the end of the "last" horizontal bar).
- Cumulative incidence of persistent patients still on index treatment at the every 3- month interval after index date (treatment initiation)
Measured: approximately 6 to 12 months
Secondary outcomes (2)
Describe and compare patient characteristics (demographics) among AF patients through questionnaire
Describe and compare patient characteristics (eg, demographics and clinical) among AF patients who:
- Initiate apixaban without previous anticoagulant treatment (warfarin or NOAC use)
- Initiate apixaban with previous war
Demographic parameters : Age-groups, Sex, Socioeconomic variables (e.g. education, disposable income)
Measured: approximately 6 to 12 months
Describe and compare patient characteristics (clinical) among AF patients through questionnaire
Describe and compare patient characteristics (eg, demographics and clinical) among AF patients who:
- Initiate apixaban without previous anticoagulant treatment (warfarin or NOAC use)
- Initiate apixaban with previous war
Clinical Characteristics: History of stroke/TIA/systemic, embolism, Diabetes, Hypertension, Heart failure, Vascular disease, Intracranial bleeding, Any bleeding, Kidney disease, Liver disease, Dementia, Valvular AF, Ischemic stroke, Unspecified stroke, TIA, Systemic embolism, Coronary disease, End Stage Renal Disease
Measured: approximately 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies 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
- 41,000 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
- NCT02492828
- Sponsor's protocol ID
- CV185-323
- Status last verified
- May 2016
- First submitted
- 30 Jun 2015
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of Apixaban and Warfarin in Patients With Atrial Fibrillation in Real-world Setting in Sweden
- ClinicalTrials.gov ID
- NCT02492828
- Acronym / sponsor ID
- CV185-323
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41,000 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jul 2015 (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.
This will be a retrospective cohort study using national register linkage data (including prescription, inpatient, mortality, and socioeconomic data). The study period will be from May 29, 2013 to June 30, 2015. Patients will be followed from the start of treatment (index date) until their death, exiting the database, or until the end of the study period (June 30, 2015).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients for filled prescriptions for apixaban | – | – |
| Patients for filled prescriptions for warfarin | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all patients with filled prescriptions for apixaban or warfarin between May 29, 2013 and Dec 31, 2014 that are identified with a hospital diagnosis of non-valvular atrial fibrillation (NVAF)
Key inclusion criteria (11 listed)
- For the AF cohort
- Apixaban subcohort 1
- Warfarin subcohort 1
- Apixaban subcohort 2
Key exclusion criteria (4 listed)
- For the AF cohort:
- Warfarin subcohort 1:
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
Compare adherence among Atrial Fibrillation (AF) patients initiating treatment with apixaban (without previous warfarin or novel anticoagulant (NOAC) use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)
Time frame: approximately 6 to 12 months
Adherence: Adherence will be defined including missing doses and treatment discontinuation using the following approaches: "Drug at disposal" approach: Based on information on prescribed dosing (mg/day) and information on filled prescriptions (mg expensed from the pharmacy); it is possible to calculate for how long a period the drug will last for that specific patient. Adherence is then defined using the Medication Possession Ratio (MPR) calculated as the ratio of number of days of treatment supply divided by the total length of follow-up time, and converted to a percentage (in the graph below illustrated as the sum of the grey horizontal bars divided by the length of follow-up, ie, time between index date and end of follow-up). The MPR will be computed as a continuous and binary variable (MPR>80%, ie, high vs low adherence)
Compare persistence among AF patients initiating treatment with apixaban (without previous warfarin or NOAC use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use)
Time frame: approximately 6 to 12 months
Persistence: Persistence will be defined as treatment discontinuation and will be measured by estimating the following: * Time to discontinuation: Date of therapy cessation is not possible to determine with certainty due to the nature of registry data. In order to be able to estimate the time of discontinuation, patients will be considered on treatment for the full time between two purchases as long as they have at least one refill in a six month period. If there is no new purchase within six months the patient is considered to have terminated treatment at a date corresponding to how long the last prescription will last (in the graph below illustrated as the time between index date and the end of the "last" horizontal bar). * Cumulative incidence of persistent patients still on index treatment at the every 3- month interval after index date (treatment initiation)
2 secondary outcomes
Describe and compare patient characteristics (demographics) among AF patients through questionnaire
Time frame: approximately 6 to 12 months
Describe and compare patient characteristics (clinical) among AF patients through questionnaire
Time frame: approximately 6 to 12 months
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 18 May 2016.
Related trials for Anticoagulation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation
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 Anticoagulation, 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 11 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 18 May 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?
Compare adherence among Atrial Fibrillation (AF) patients initiating treatment with apixaban (without previous warfarin or novel anticoagulant (NOAC) use) compared with those initiating treatment with warfarin (without previous warfarin or NOAC use) (time frame: approximately 6 to 12 months). The study lists 2 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 18 May 2016.