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Clinical Trials/NCT03572972
NCT03572972CompletedNot Applicable

THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA

Pfizer1 site in 1 country64,684 target enrollmentStarted: January 31, 2018Last updated:
Conditions
Interventions

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))

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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