CompletedNot Applicable

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

Japan193,565 participantsStarted 2022-04-15

Plain-language 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).

Who can participate

Age range20 Years

SexALL

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Inclusion criteria

✓. Patients registered in the Medical Data Vision (MDV) database 2008 though 2021.
✓. Patients newly with non-valvular atrial fibrillation
✓. Patients who newly receive warfarin or apixaban after diagnosis of NVAF
✓. Age 20 years or older on the index date
✓. 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 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.
✕. Patients with a diagnosis of venous thromboembolism (VTE) during the baseline period
✕. Patients who are prescribed any anticoagulants before index date.
✕. Patients who are prescribed anticoagulants other than warfarin and apixaban on the index date
✕. Patients who are continuously hospitalized due to the first incidence of stroke or other serious diseases.

What they're measuring

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])

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

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

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

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

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

Trial details

NCT IDNCT05321810

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-04-15

Results submitted2023-03-29

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation trials