- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05438888
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
Safety and Effectiveness of Apixaban in Very Elderly Patients With NVAF Compared to Warfarin Using Administrative Claims Data
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a retrospective non-intervention observational study to evaluate the difference in safety and effectiveness between apixaban and warfarin using a database provided by Medical Data Vision Co. Ltd. (MDV Co. Ltd.). Eligible patients will be extracted from the database and allocated to the pre-defined cohorts based on the actual age, age of NVAF diagnosis and types of anticoagulant therapy.
Patient characteristics will be balanced by an Inverse probability of treatment weighting (IPTW) method, and risk of stroke/SE (primary effectiveness endpoint) and major bleeding (primary safety endpoint) will be compared.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tokyo, Japan
- Pfizer Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.
- Diagnosed with Atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
- Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
- No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)
- Age of 18 years or older on the index date.
- Index date is at age 80 or older
Exclusion Criteria:
Patients meeting any of the following criteria will not be included in the study:
- Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
- Having a cardiac surgery procedure record during the baseline period
- Having a joint replacement procedure record during the baseline period
- Having a procedure of prosthetic heart valve during the baseline period
- Having a diagnosis of venous thromboembolism during the baseline period
- Female patients with pregnancy during the follow-up period
- Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Warfarin cohort (Reference)
Patients with NVAF treated with warfarin
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This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings.
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Apixaban cohort
Patients with NVAF treated with apixaban
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This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to incidence of a composite stroke and of systemic embolism
Time Frame: Maximum of 8 years (From 26 February 2013 to 31 December 2021)
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Maximum of 8 years (From 26 February 2013 to 31 December 2021)
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Time to Incidence of Systemic Embolism
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Time to incidence of major bleeding
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Major bleeding is defined as any bleeding requiring hospitalization.
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Incidence of Cardiogenic Cerebral Embolism
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Time to Incidence of Cerebral Infarction
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Time to Incidence of Intracranial Hemorrhage
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Time to Incidence of Gastrointestinal Bleeding
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Time to Incidence of Intraocular Bleeding
Time Frame: Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0661181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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