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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198844
Recruitment Status : Withdrawn (Interaction term analysis result was not significant and thus comparative effectiveness for primary and secondary outcomes could not be considered per protocol.)
First Posted : December 13, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: warfarin Drug: apixaban

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : November 18, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020


Group/Cohort Intervention/treatment
Warfarin user Drug: warfarin
warfarin user

Apixaban user Drug: apixaban
apixaban user




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    Intake period is from July 1, 2015 to Nov 30, 2016.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Non-valvular atrial fibrillation patients with warfarin or apixaban user
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198844


Locations
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Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 04631
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04198844    
Other Study ID Numbers: B0661126
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (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/data_requests.
Additional relevant MeSH terms:
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Osteoporosis
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Warfarin
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action