Atrial FibrillationNCT04198844
The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
An observational study of Atrial Fibrillation, run by Pfizer at 1 site in South Korea.
Trial summary
Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- warfarin and apixaban
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2019to 31 Mar 2020
- 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: Non-valvular atrial fibrillation patients with warfarin or apixaban user
Who may be able to join
- Patients aged 18 years or older on the index date
- Patients had ≥1 medical claim for atrial fibrillation with at least one hospitalization or at least two outpatient visits during the reference period
Who cannot join
- Patients with valvular atrial fibrillation or transient atrial fibrillation
- Having ≥ 2 types of oral anticoagulant on the index date
- who have contraindications to oral anticoagulant
- confounder factors related to the outcome (osteoporotic fractures)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture. Therefore, in real world, these risk factors and co-morbidities are commonly considered when it comes to prescribe anticoagulant in atrial fibrillation patients. Recent study even reported that comorbid atrial fibrillation in patients with osteoporosis might be associated with an increased risk of bone fracture and death after fracture. Because there have been very few data about the effectiveness/safety of anticoagulant among non-valvular atrial fibrillation with prior osteoporosis/fracture, this study is planned to provide real-world evidences for this specific type of non-valvular atrial fibrillation patients.
- 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 |
|---|---|---|
| Warfarin user | Not described Receives: Drug: warfarin | |
| Apixaban user | Not described Receives: Drug: apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism
Intake period is from July 1, 2015 to Nov 30, 2016.
Measured: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period(the index date- Nov 30, 2016 or outcomes whichever comes first)
Secondary outcomes (1)
Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding
Intake period is from July 1, 2015 to Nov 30, 2016.
Measured: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period (the index date- Nov 30, 2016 or outcomes whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start18 Nov 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Why it stopped: Interaction term analysis result was not significant and thus comparative effectiveness for primary and secondary outcomes could not be considered per protocol.
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 PfizerThe 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
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198844
- Sponsor's protocol ID
- B0661126
- Status last verified
- May 2020
- First submitted
- 2 Dec 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Apixaban Versus Warfarin in Non-valvular Atrial Fibrillation (NVAF) Patients With the History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
- ClinicalTrials.gov ID
- NCT04198844
- Acronym / sponsor ID
- B0661126
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Interaction term analysis result was not significant and thus comparative effectiveness for primary and secondary outcomes could not be considered per protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 13 Dec 2019 (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.
Old age, less body weight and deteriorated renal function are significant clinical factors for the outcomes of atrial fibrillation- so called 'fragile'- and these are common risk factors in osteoporosis and fracture. Therefore, in real world, these risk factors and co-morbidities are commonly considered when it comes to prescribe anticoagulant in atrial fibrillation patients. Recent study even reported that comorbid atrial fibrillation in patients with osteoporosis might be associated with an increased risk of bone fracture and death after fracture. Because there have been very few data about the effectiveness/safety of anticoagulant among non-valvular atrial fibrillation with prior osteoporosis/fracture, this study is planned to provide real-world evidences for this specific type of non-valvular atrial fibrillation patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin user | – | Drug: warfarin |
| Apixaban user | – | Drug: apixaban |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-valvular atrial fibrillation patients with warfarin or apixaban user
Key inclusion criteria (2 listed)
- Patients aged 18 years or older on the index date
- Patients had ≥1 medical claim for atrial fibrillation with at least one hospitalization or at least two outpatient visits during the reference period
Key exclusion criteria (4 listed)
- Patients with valvular atrial fibrillation or transient atrial fibrillation
- Having ≥ 2 types of oral anticoagulant on the index date
- who have contraindications to oral anticoagulant
- confounder factors related to the outcome (osteoporotic fractures)
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 |
|---|---|---|
| warfarinwarfarin user | Drug | Warfarin user |
| apixabanapixaban user | Drug | Apixaban user |
Primary outcome
Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism
Time frame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period(the index date- Nov 30, 2016 or outcomes whichever comes first)
Intake period is from July 1, 2015 to Nov 30, 2016.
1 secondary outcome
Major bleeding including gastrointestinal bleeding, intracranial bleeding, and other bleeding
Time frame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period (the index date- Nov 30, 2016 or outcomes whichever comes first)
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 1 Jun 2020.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Atrial Fibrillation, run by Pfizer at 1 site in South Korea.
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 2 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: withdrawn, as of the sponsor's last update on 1 Jun 2020. 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 South Korea. 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?
Composite of ischemic stroke, hemorrhagic stroke and and systemic embolism (time frame: from index date (1st prescription date for oral anticoagulants during the intake period) to follow up period(the index date- Nov 30, 2016 or outcomes whichever comes first)). 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 1 Jun 2020.