Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fi… (NCT05471505) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding
Japan120,722 participantsStarted 2022-08-25
Plain-language summary
* The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database.
* Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots.
* An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients.
* Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial.
* Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s).
* This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (OACs) during the baseline period (the 180 days before the index date)
* Age of 18 years or older on the index date
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 procedure of prosthetic heart valve during the baseline period
* Having a cardiac surgery procedure record during the baseline period
* Having a diagnosis of venous thromboembolism during the baseline period
* Having a hemodialysis during the baseline period
* Female patients with pregnancy during the baseline and follow-up period
* Patients prescribed apixaban other than approved daily dose (\<5 mg or \>10 mg)
* Patients prescribed OACs during baseline period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rate Per 1000 Participant-Years For First Occurrence of Composite Stroke and Systemic Embolism (SE) Events After Index Date: Balanced Cohorts
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study
2
Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Bleeding Event After Index Date: Balanced Cohorts
Timeframe: Follow-up period during data observation period from Mar 2011 to Jun 2021 (approximately 10 years 4 months); extracted data evaluated in approximately 1 month of this study