The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study
NCT04198844
Last updated date
ABOUT THIS 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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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)
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based 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 | ||||
| Brief 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. 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Non-valvular atrial fibrillation patients with warfarin or apixaban user | ||||
| Condition | Atrial Fibrillation | ||||
| Intervention |
| ||||
| Study Groups/Cohorts |
| ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Withdrawn | ||||
| Actual Enrollment | 0 | ||||
| Original Actual Enrollment | 1 | ||||
| Estimated Study Completion Date | March 31, 2020 | ||||
| Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04198844 | ||||
| Other Study ID Numbers | B0661126 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | May 2020 | ||||