Clinical trial NCT05321810: Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With Atrial Fibrillation
Official title: Safety and Effectiveness of Apixaban Compared to Warfarin in Secondary Prevention in Patients With NVAF With a History of Stroke or Transient Ischemic Attack - a Nationwide Retrospective Observational Study Using Claims Data in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation
Stroke
Apixaban
Warfarin
Secondary prevention
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 193565
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Secondary prevention patients who are newly diagnosed with NVAF and initiate anticoagulation therapy with warfarin or apixaban.

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.

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
5. Patients who have a history of stroke or transient ischemic attack (TIA) are inclusion criteria only for secondary prevention cohort, otherwise patients will be concluded in the primary prevention cohort.

Exclusion Criteria:

Patients who meet the following exclusion criteria will be excluded from this study

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.

Primary outcomes:
measure: Incidence Rate of a Composite of Recurrent Stroke or Systemic Embolism (SE) During the Follow-up Period: Secondary Prevention (Balanced) Cohort
timeFrame: During follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 0 Month: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month
measure: Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 6 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 6 months
measure: Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 12 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 12 months
measure: Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 18 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 18 months
measure: Time Course of Proportion of the Incidence of a Composite of Recurrent Stroke or Systemic Embolism (SE)-Free Participants at 24 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 24 months
measure: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 0 Month: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month
measure: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 6 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 6 months
measure: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 12 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 12 months
measure: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 18 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 18 months
measure: Number of Participants With Risk of a Composite of Recurrent Stroke or SE at 24 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 24 months
measure: Incidence Rate of Major Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts
timeFrame: During follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 0 Month: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month
measure: Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 6 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 6 months
measure: Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 12 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 12 months
measure: Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 18 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 18 months
measure: Time Course of Proportion of Incidence of Major Bleeding-Free Participants at 24 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 24 months
measure: Number of Participants With Risk of Major Bleeding at 0 Month: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month
measure: Number of Participants With Risk of Major Bleeding at 6 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 6 months
measure: Number of Participants With Risk of Major Bleeding at 12 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 12 months
measure: Number of Participants With Risk of Major Bleeding at 18 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 18 months
measure: Number of Participants With Risk of Major Bleeding at 24 Months: Secondary Prevention (Balanced) Cohorts
timeFrame: 24 months
Secondary outcomes:
measure: Incidence Rate of Recurrent Cardiogenic Cerebral Embolism During the Follow-up Period: Secondary Prevention (Balanced) Cohorts
timeFrame: During follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of Incidence of Recurrent Cardiogenic Cerebral Embolism-Free Participants: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Number of Participants With Risk of Recurrent Cardiogenic Cerebral Embolism: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Incidence Rate of Recurrent Cerebral Infarction During the Follow-up Period: Secondary Prevention (Balanced) Cohorts
timeFrame: During Follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of Incidence of Recurrent Cerebral Infarction-Free Participants: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Number of Participants With Risk of Recurrent Cerebral Infarction: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Incidence Rate of Intracranial Hemorrhage During the Follow-up Period: Secondary Prevention (Balanced) Cohorts
timeFrame: During follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of Incidence of Intracranial Hemorrhage-Free Participants: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Number of Participants With Risk of Intracranial Hemorrhage: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Incidence Rate of Gastrointestinal Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts
timeFrame: During follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of Incidence of Gastrointestinal Bleeding-Free Participants: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Number of Participants With Risk of Gastrointestinal Bleeding: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Incidence Rate of Intraocular Bleeding During the Follow-up Period: Secondary Prevention (Balanced) Cohorts
timeFrame: During follow up period (Data collected between 2008 to 2021 [approximately 13 years])
measure: Time Course of Proportion of Incidence of Intraocular Bleeding-Free Participants: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
measure: Number of Participants With Risk of Intraocular Bleeding: Secondary Prevention (Balanced) Cohorts
timeFrame: 0 month, 6 months, 12 months, 18 months and 24 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: