Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea (NCT03572972) | Clinical Trial Compass
CompletedNot Applicable
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
South Korea64,684 participantsStarted 2018-01-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged 18 years or older on the index date
✓. 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:
✓. Patients prescribed aspirin, warfarin, or NOACs during intake period (from July 1, 2015 to November 30, 2016)
Exclusion criteria
✕. Medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
✕. 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)
✕. Medical claims indicating a diagnosis code of VTE (Venous thromboembolism) during the 12-month baseline period
✕. 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)
✕. Medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (End-stage chronic kidney disease / Kidney transplant / Dialysis / Pericarditis)
✕. 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)
✕
What they're measuring
1
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)
2
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)
3
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)
4
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)
. 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)