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

Non-valvular Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438888
• Other study ID #: B0661181
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: October 19, 2022

Study information

• Verified date: September 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77814
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Patients must meet all the following inclusion criteria to be eligible for inclusion in the study.

1. 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.

2. 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

3. No use of the any Oral anticoagulants (OAC)s during the baseline period (the 180 days before the index date)

4. Age of 18 years or older on the index date.

5. Index date is at age 80 or older

Exclusion Criteria:

• Patients meeting any of the following criteria will not be included in the study:

1. 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

2. Having a cardiac surgery procedure record during the baseline period

3. Having a joint replacement procedure record during the baseline period

4. Having a procedure of prosthetic heart valve during the baseline period

5. Having a diagnosis of venous thromboembolism during the baseline period

6. Female patients with pregnancy during the follow-up period

7. 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Japan	Pfizer Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to incidence of a composite stroke and of systemic embolism		Maximum of 8 years (From 26 February 2013 to 31 December 2021)
Primary	Time to Incidence of Systemic Embolism		Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
Primary	Time to incidence of major bleeding	Major bleeding is defined as any bleeding requiring hospitalization.	Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
Secondary	Time to Incidence of Cardiogenic Cerebral Embolism		Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
Secondary	Time to Incidence of Cerebral Infarction		Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
Secondary	Time to Incidence of Intracranial Hemorrhage		Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
Secondary	Time to Incidence of Gastrointestinal Bleeding		Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)
Secondary	Time to Incidence of Intraocular Bleeding		Maximum of 8 years (From 26 February, 2013 to 31 December, 2021)

External Links

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