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

NCT05438888 | Completed Results

• 1 other identifier: B0661181
• Study Type: observational
• Target: 77,814
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation

Keywords

Stroke; Apixaban; Warfarin

Outcome Measures

Primary Outcomes (2)

• Incidence Rate (Per 1,000 Participant-Year) of Composite of Stroke and Systemic Embolism (SE): Balanced Cohorts

  Incidence rate per 1000 participant-years for the first occurrence of composite stroke and SE events after index date was reported. Stroke events included ischemic and hemorrhagic stroke. International Classification of Diseases 10th Revision (ICD-10) diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first.

  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

• Incidence Rate (Per 1,000 Participant-Year) of Major Bleeding: Balanced Cohorts

  Incidence rate per 1000 participant-years for the first occurrence of major bleeding event after index date was reported. Major bleeding was defined as any bleeding that required hospitalization for treatment. ICD-10 diagnosis code was used to label the events. Index date was defined as a date when participants initiated warfarin or apixaban. Follow-up period: the next day of the index date till occurrence of target outcome, discontinuation of the warfarin or apixaban, switching from the warfarin or apixaban, withdrawal from the database, whichever observed first.

  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

Secondary Outcomes (5)

• Incidence Rate (Per 1,000 Participant-Year) of Cardiogenic Cerebral Embolism: Balanced Cohorts

  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

• Incidence Rate (Per 1,000 Participant-Year) of Ischemic Stroke (Cerebral Infarction): Balanced Cohorts

  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

• Incidence Rate (Per 1,000 Participant-Year) of Intracranial Hemorrhage: Balanced Cohorts

  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

• Incidence Rate (Per 1,000 Participant-Year) of Gastrointestinal Bleeding: Balanced Cohorts

  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

• Incidence Rate (Per 1,000 Participant-Year) of Intraocular Bleeding: Balanced Cohorts

  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

Study Arms (2)

Warfarin cohort (Reference)

Patients with NVAF treated with warfarin

Drug: Warfarin

Apixaban cohort

Patients with NVAF treated with apixaban

Drug: Apixaban

Interventions

Warfarin DRUG

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

Warfarin cohort (Reference)

Apixaban DRUG

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

Apixaban cohort

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 80 years or older who are newly diagnosed with non-valvular atrial fibrillation (NVAF) and initiate anticoagulation therapy with warfarin or apixaban.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Site

Tokyo, Japan

Location

Related Publications (1)

• Matsuo-Ohsawa A, Katada J, Kohsaka S. Safety and Effectiveness of Apixaban in Very Elderly Patients with Atrial Fibrillation: A Retrospective Analysis of Japanese Administrative Claims Data. Cardiol Ther. 2025 Dec;14(4):565-581. doi: 10.1007/s40119-025-00420-w. Epub 2025 Jul 8.

  PMID: 40627071 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Stroke

Interventions

Warfarin; apixaban

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: June 30, 2022
• Study Start: July 1, 2022
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)