Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

Pfizer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Apixaban; Drug: Antiplatelets; Drug: Rivaroxaban; Drug: warfarin; Drug: Dabigatran

Study type: Observational

Funder types: Industry

Identifiers

NCT03572972

X9001134

Details and patient eligibility

About

The primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using Korean nationwide health claims database.

Enrollment: 64,684 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18 years or older on the index date
2. Patients had ≥1 medical claim for AF (refer to Table 1) before or on the index date with at least one hospitalization or at least two outpatient visits:
3. Patients prescribed aspirin, warfarin, or NOACs during intake period (from July 1, 2015 to November 30, 2016)

Exclusion criteria

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

1. Medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date

2. Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis during the 12-month baseline period (Valvular AF / Prosthetic heart valves)

3. Medical claims indicating a diagnosis code of VTE (Venous thromboembolism) during the 12-month baseline period

4. Medical claims indicating a diagnosis or procedure code of transient AF, or cardiac surgery during the 12-month baseline period (Thyrotoxicosis, Hypertrophic cardiomyopathy, Elective defibrillation, radiofrequency ablation, or left atrial appendage occlusion)

5. Medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (End-stage chronic kidney disease / Kidney transplant / Dialysis / Pericarditis)

6. For the comparison of "NOAC versus NOAC", and "NOAC versus warfarin", patients with any OACs (apixaban, dabigatran, rivaroxaban, or warfarin) in the pre-index period (from 1 year prior to the day before index date)

7. For the comparison of "NOAC versus aspirin", patients with following medications in the pre-index period (from 1 year prior to the day before index date)

   • NOAC user: OACs (apixaban, dabigatran, rivaroxaban, warfarin)
   • Aspirin user: none

Trial design

64,684 participants in 5 patient groups

Patients prescribed apixaban

Treatment:

Drug: Apixaban

Patients prescribed dabigatran

Treatment:

Drug: Dabigatran

Patients prescribed rivaroxaban

Treatment:

Drug: Rivaroxaban

Patients prescribed warfarin

Treatment:

Drug: warfarin

Patients prescribed antiplatelet

Treatment:

Drug: Antiplatelets