Clinical trial NCT03572972: Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
Official title: THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-06-28
Enrollment: 64684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from Korean Health Insurance Review \& Assessment Service (HIRA) database according to the inclusion/exclusion criteria. Only users of oral anticoagulant or antiplatelet treatment for atrial fibrillation from July 1, 2015 to November 30, 2016 will be included in this study.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Secondary outcomes:
measure: Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
measure: Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
timeFrame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lee MY, Han S, Bang OY, On YK, Jang SW, Han S, Ryu J, Park YJ, Kang S, Suh HS, Kim YH. Drug Utilization Pattern of Oral Anticoagulants in Patients with Atrial Fibrillation: A Nationwide Population-Based Study in Korea. Adv Ther. 2022 Jul;39(7):3112-3130. doi: 10.1007/s12325-022-02151-z. Epub 2022 May 7.