Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05438888

Collaborator

(none)

150,000

Enrollment

Location

5.9

Anticipated Duration (Months)

25224.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-valvular Atrial Fibrillation	Drug: Warfarin Drug: Apixaban

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 Design

Study Type:

Observational

Anticipated Enrollment :

150000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Safety and Effectiveness of Apixaban in Very Elderly Patients With NVAF Compared to Warfarin Using Administrative Claims Data

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 29, 2022

Anticipated Study Completion Date :

Dec 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Warfarin cohort (Reference) Patients with NVAF treated with warfarin	Drug: Warfarin This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings.
Apixaban cohort Patients with NVAF treated with apixaban	Drug: Apixaban This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings.

Arm

Intervention/Treatment

Warfarin cohort (Reference)

Patients with NVAF treated with warfarin

Drug: Warfarin

This is observational study and the patients in the warfarin cohort include those who are exposed to warfarin in the real world settings.

Apixaban cohort

Patients with NVAF treated with apixaban

Drug: Apixaban

This is observational study and the patients in the apixaban cohort include those who are exposed to apixaban in the real world settings.

Outcome Measures

Primary Outcome Measures

Time to incidence of a composite stroke and of systemic embolism [Maximum of 14 years (From 2008 to 2021)]
Time to Incidence of Systemic Embolism [Maximum of 14 years (From 2008 to 2021)]
Time to incidence of major bleeding [Maximum of 14 years (From 2008 to 2021)]
Major bleeding is defined as any bleeding requiring hospitalization.

Secondary Outcome Measures

Time to Incidence of Cardiogenic Cerebral Embolism [Maximum of 14 years (From 2008 to 2021)]
Time to Incidence of Cerebral Infarction [Maximum of 14 years (From 2008 to 2021)]
Time to Incidence of Intracranial Hemorrhage [Maximum of 14 years (From 2008 to 2021)]
Time to Incidence of Gastrointestinal Bleeding [Maximum of 14 years (From 2008 to 2021)]
Time to Incidence of Intraocular Bleeding [Maximum of 14 years (From 2008 to 2021)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.