AnticoagulationNCT02591732
A Nationwide Registry Study of Patients With Nonvalvular Atrial Fibrillation Initiating Oral Anticoagulation Therapies In The Early Period Following Apixaban Marketing In Denmark
An observational study of Anticoagulation, run by Bristol-Myers Squibb at 1 site in Denmark.
Trial summary
The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments. Furthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- How many people
- 52,178 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject must be over 18 years of age, male and females are eligible
Who may be able to join
- The study population will consist of all patients in Denmark who meet the following criteria:
- Adult (≥18 years) at time of anticoagulant initiation
- Diagnosed with atrial fibrillation without recorded valvular disease
- Initiated a new OAT during the study period (January 1, 2011 and December 31, 2014).
- For the identification of NVAF cases, the appearance at least one hospital discharge diagnosis of AF will be searched in the databases.
Who cannot join
- Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nation-wide Registry Study of Patients With Non-valvular Atrial Fibrillation Initiating Anticoagulation Therapies in the Early Period Follow Apixaban Marketing in Denmark: Patient Characteristics, Treatment Patterns, and Early Bleeding Events
The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments.
Furthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT.
- 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 |
|---|---|---|
| Patient treated with Apixaban | Not described | |
| Patient treated with Rivaroxaban | Not described | |
| Patient treated with Dabigatran | Not described | |
| Patient treated with vitamin K antagonists | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry
Sociodemographic characteristics: Age,sex, ethnicity, region of residence, education, income and employment status
Measured: Approximately 4 years
Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry
Clinical characteristics: Myocardial infarction, Stroke, Thromboembolism, Hypertension, Peripheral artery disease, Congestive cardiac failure
Measured: Approximately 4 years
Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
Oral anticoagulant: Apixaban, Dabigatran, Rivaroxaban and Vitamin K antagonist
Measured: Approximately 4 years
Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
Concomitant medication Drug classes: Anti-arrhythmic agents, Antidiabetic agents, Antihypertensive agents, Proton pump inhibitors
Measured: Approximately 4 years
Secondary outcomes (7)
Persistence to each OAT after initiation as monotherapy
Persistence will be defined as treatment discontinuation and will be measured by estimating the following:
Discontinuation - the absence of any delivery of this product and of any other anticoagulation therapy of interest for 30 days. The date of discontinuation the OAT will be determined according to predefined algorithms to calculate treatment duration in the national prescription registry. Sensitivity analysis including a 30 and 60 day grace period will be performed to take into account incomplete adherence to treatment and dose modifications
Measured: Approximately 4 years
Persistence between apixaban and other OAT
Oral anticoagulant: Dabigatran, Rivaroxaban and Vitamin K antagonist
Measured: Approximately 4 years
Clinically relevant bleeding events after initiating an OAT as monotherapy
Measured: Approximately 4 years
Bleeding events requiring hospitalization in patients treated with apixaban
Measured: Approximately 4 years
Bleeding events requiring out-patient care in patients treated with apixaban
Measured: Approximately 4 years
Bleeding events requiring hospitalization in patients treated with rivaroxaban
Measured: Approximately 4 years
Bleeding events requiring out-patient care in patients treated with rivaroxaban
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 52,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591732
- Sponsor's protocol ID
- CV185-377
- Status last verified
- May 2016
- First submitted
- 8 Oct 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
- A Nation-wide Registry Study of Patients With Non-valvular Atrial Fibrillation Initiating Anticoagulation Therapies in the Early Period Follow Apixaban Marketing in Denmark: Patient Characteristics, Treatment Patterns, and Early Bleeding Events
- ClinicalTrials.gov ID
- NCT02591732
- Acronym / sponsor ID
- CV185-377
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52,178 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Oct 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.
The purpose of this study is to describe the characteristics of patients treated with different OATs and whether these characteristics differ between treatments.
Furthermore to describe persistence to each OAT and risk of bleeding after initiating each OAT.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient treated with Apixaban | – | – |
| Patient treated with Rivaroxaban | – | – |
| Patient treated with Dabigatran | – | – |
| Patient treated with vitamin K antagonists | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject must be over 18 years of age, male and females are eligible
Key inclusion criteria (5 listed)
- The study population will consist of all patients in Denmark who meet the following criteria:
- Adult (≥18 years) at time of anticoagulant initiation
- Diagnosed with atrial fibrillation without recorded valvular disease
- Initiated a new OAT during the study period (January 1, 2011 and December 31, 2014).
- For the identification of NVAF cases, the appearance at least one hospital discharge diagnosis of AF will be searched in the databases.
Key exclusion criteria (1 listed)
- Patients with prosthetic heart valves , rheumatic mitral or aortic valve disorders, and mitral aortic stenosis will be excluded
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
The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry
Time frame: Approximately 4 years
Sociodemographic characteristics: Age,sex, ethnicity, region of residence, education, income and employment status
Clinical characteristics of all patients with NVAF who initiated an Oral anticoagulant therapy (OAT) based on data available in Danish National Patient Registry
Time frame: Approximately 4 years
Clinical characteristics: Myocardial infarction, Stroke, Thromboembolism, Hypertension, Peripheral artery disease, Congestive cardiac failure
Previous Oral anticoagulant therapy of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
Time frame: Approximately 4 years
Oral anticoagulant: Apixaban, Dabigatran, Rivaroxaban and Vitamin K antagonist
Concomitant medications of all patients with NVAF who initiated an OAT based on data available in Danish National Patient Registry
Time frame: Approximately 4 years
Concomitant medication Drug classes: Anti-arrhythmic agents, Antidiabetic agents, Antihypertensive agents, Proton pump inhibitors
7 secondary outcomes
Persistence to each OAT after initiation as monotherapy
Time frame: Approximately 4 years
Persistence between apixaban and other OAT
Time frame: Approximately 4 years
Clinically relevant bleeding events after initiating an OAT as monotherapy
Time frame: Approximately 4 years
Bleeding events requiring hospitalization in patients treated with apixaban
Time frame: Approximately 4 years
Bleeding events requiring out-patient care in patients treated with apixaban
Time frame: Approximately 4 years
Bleeding events requiring hospitalization in patients treated with rivaroxaban
Time frame: Approximately 4 years
Bleeding events requiring out-patient care in patients treated with rivaroxaban
Time frame: Approximately 4 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 18 May 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
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 Anticoagulation, run by Bristol-Myers Squibb at 1 site in Denmark.
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 5 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 18 May 2016. 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 Denmark. 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?
The sociodemographic characteristics of all patients with nonvalvular atrial fibrillation (NVAF) who initiated an OAT based on data available in Danish National Patient Registry (time frame: Approximately 4 years). The study lists 4 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.