N/A
Completed N=64,684
Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea
Source: ClinicalTrials.gov NCT03572972 ↗Enrolled (actual)
64,684
Serious AEs
—
Results posted
Feb 2020
Primary outcomePrimary: Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis — 7.66; 13.52; 7.2; 13.53 events per 100 participants-years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis |
7.66; 13.52; 7.2; 13.53; 7.18; 12.89 | — |
| PRIMARY Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis |
7.75; 7.47; 7.35; 7.48; 7.01; 7.31 | — |
| PRIMARY Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis |
7.97; 14.73; 8.57; 13.77; 9.55; 14.23 | — |
| PRIMARY Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis |
7.70; 8.65; 7.77; 9.86; 8.18; 9.36 | — |
| SECONDARY Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis |
1.1; 1.73; 0.78; 1.71; 1.18; 1.72 | — |
| SECONDARY Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis |
1.11; 0.74; 1.05; 1.15; 0.71; 1.14 | — |
| SECONDARY Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis |
6.9; 11.8; 6.53; 11.92; 6.29; 11.19 | — |
| SECONDARY Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis |
6.99; 6.84; 6.60; 6.58; 6.37; 6.43 | — |
| SECONDARY Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis |
0.18; 0.78; 0.24; 0.75; 0.27; 0.74 | — |
| SECONDARY Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis |
0.20; 0.25; 0.20; 0.28; 0.24; 0.26 | — |
| SECONDARY Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis |
3.44; 6.2; 4.17; 5.56; 4.32; 5.78 | — |
| SECONDARY Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis |
3.23; 4.18; 3.28; 4.59; 3.97; 4.25 | — |
| SECONDARY Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis |
1.37; 2.38; 1.17; 2.31; 1.47; 2.37 | — |
| SECONDARY Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis |
1.39; 1.12; 1.35; 1.43; 1.08; 1.41 | — |
| SECONDARY Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis |
3.75; 6.93; 3.86; 6.61; 4.42; 6.85 | — |
| SECONDARY Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis |
3.67; 4.06; 3.73; 4.54; 3.83; 4.35 | — |
Eligibility Criteria
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
Patients meeting any of the following criteria will not be included in the study.
- 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)
- 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
Data sourced from ClinicalTrials.gov (NCT03572972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.