Clinical trial NCT05471505: 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
Official title: Safety and Effectiveness of Apixaban Compared to Warfarin in NVAF Patients at Higher Risk of Bleeding.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 120722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study uses data from the MDV database, which includes the data used for both inpatient and outpatient insurance claims by hospitals according to the Diagnosis Procedure Combination (DPC) procedure.

The study population will consist of adults with NVAF who are newly prescribed apixaban or warfarin.

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Incidence Rate Per 1000 Participant-Years For First Occurrence of Ischemic Stroke 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
measure: Incidence Rate Per 1000 Participant-Years For First Occurrence of Hemorrhagic Stroke 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
measure: Incidence Rate Per 1000 Participant-Years For First Occurrence of Systemic Embolism (SE) 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
measure: Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Intracranial 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
measure: Incidence Rate Per 1000 Participant-Years For First Occurrence of Major Gastrointestinal (GI) 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
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: