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Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

Last updated on May 8, 2019

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Study Location
Pfizer Japan
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-valvular Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Patients must meet all of the following criteria to be eligible for the study:

1. Diagnosed with 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 one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban 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 OACs during the baseline period (the 180 days before the index date)

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

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NCT03570047
Pfizer
Completed
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

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