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The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study

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NCT04198844

Last updated on January 16, 2020
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Study Location
Pfizer Investigational Site
Seoul, , 04631 Korea, Republic of
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Contact
1-800-718-1021
[email protected]
Related Links
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
0 +
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)

NCT04198844
Pfizer
Active, not recruiting
The Effectiveness and Safety of Apixaban in NVAF Patients With History of Osteoporosis and/or Fracture: A Nation-wide Population Based Study

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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
  • Drug: warfarin
    warfarin user
  • Drug: apixaban
    apixaban user
Study Groups/Cohorts
  • Warfarin user
    Intervention: Drug: warfarin
  • Apixaban user
    Intervention: Drug: apixaban
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 Active, not recruiting
Actual Enrollment
 (submitted: December 11, 2019) 		1
Original Actual Enrollment Same as current
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:

  • 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:

  • 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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, 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
Plan to Share IPD: No
Plan Description: 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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2019

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