Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation

NCT ID: NCT05321810

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 193565 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2022-04-15

Brief Summary

The purpose of this study are 1) to characterize the primary and secondary prevention patients, 2) to calculate incidence rates of stroke/SE or major bleeding in each cohort and 3) to investigate for Japanese secondary prevention patients as Real World Evidence (RWE) on the effectiveness and safety of apixaban compared to warfarin in patients with non-valvular atrial fibrillation (NVAF).

Detailed Description

Japanese population has shown to have higher rate of incidence of stroke and stroke mortality is also higher. Patients with a history of ischemic stroke are at high risk of recurrence and require more rigorous management to prevent recurrence. The same is true for patients with non-valvular atrial fibrillation (NVAF) and treatment with anticoagulants reduces the risk of recurrent embolic stroke. However, some patients still suffer from recurrent embolic and/or ischemic stroke even if they are on anticoagulants for secondary prevention. In addition to the recurrent stroke, risk of bleeding is also higher in the patients with a history of stroke because they are often chronically treated with antiplatelet agents to prevent recurrence after cerebral infarction and with an anticoagulant after embolic stroke. Concomitant use of anticoagulant and anti-platelet agents is sometimes necessary if patients with AF experience cerebral infarction and the risk of bleedings largely enhances in these patients. Thus, patients in secondary prevention are at higher risk of both recurrent ischemic stroke and more effective and safer antithrombotic therapy should take this into account.

The purpose of this study are 1) to characterize the primary and secondary prevention patients, 2) to calculate incidence rates of stroke/SE or major bleeding in each cohort and 3) to investigate for Japanese secondary prevention patients as RWE on the effectiveness and safety of apixaban compared to warfarin in patients NVAF.

Conditions

Non-valvular Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Warfarin cohort (Reference)

Patients with NVAF treated with warfarin

Warfarin

Intervention Type: DRUG

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

Apixaban

Intervention Type: DRUG

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

Interventions

Apixaban

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients must meet all the following selection criteria

1. Patients registered in the Medical Data Vision (MDV) database 2008 though 2021.

2. Patients newly with non-valvular atrial fibrillation

3. Patients who newly receive warfarin or apixaban after diagnosis of NVAF

4. Age 20 years or older on the index date

Exclusion Criteria

1. Patients with a diagnosis of valvular AF (standard disease code: 8846941), postoperative AF (8847772), AF associated with mechanical valve malfunction (T82.0), mechanical complication of heart valve prosthesis (T82.0), or rheumatic AF (I05-I09) during the baseline period.

2. Patients with a diagnosis of venous thromboembolism (VTE) during the baseline period

3. Patients who are prescribed any anticoagulants before index date.

4. Patients who are prescribed anticoagulants other than warfarin and apixaban on the index date

5. Patients who are continuously hospitalized due to the first incidence of stroke or other serious diseases.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B0661176

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

Other Identifiers

Secondary prevention

Identifier Type: OTHER

Identifier Source: secondary_id

B0661176

Identifier Type: -

Identifier Source: org_study_id