Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillati… (NCT05438888) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
Japan77,814 participantsStarted 2022-07-01
Plain-language summary
The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF). In addition to the absolute age, effects on higher age-related risk factors on relative risk of apixaban to warfarin is also investigated through subgroup analyses.
Who can participate
Age range80 Years
SexALL
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Inclusion criteria
✓. 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
✕. 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
✕
What they're measuring
1
Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study
2
Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts
Timeframe: Follow-up period during data observation period from 26-Feb-2013 to 31-Dec-2021 (approximately 8 years 10 months); extracted data evaluated in approximately 3.5 months of this study
. 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.