THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 64,684
- Locations
- 1
- Primary Endpoint
- Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Patients prescribed apixaban
Intervention: Apixaban (Drug)
Patients prescribed dabigatran
Intervention: Dabigatran (Drug)
Patients prescribed rivaroxaban
Intervention: Rivaroxaban (Drug)
Patients prescribed warfarin
Intervention: warfarin (Drug)
Patients prescribed antiplatelet
Intervention: Antiplatelets (Drug)
Outcomes
Primary Outcomes
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
Time Frame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
Time Frame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration.
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
Time Frame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration.
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
Time Frame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.
Secondary Outcomes
- Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
- Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis(Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016))
