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Clinical Trials/NCT03572972
NCT03572972
Completed
Not 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 enrollmentJanuary 31, 2018

Overview

Phase
Not Applicable
Intervention
Apixaban
Conditions
Atrial Fibrillation
Sponsor
Pfizer
Enrollment
64684
Locations
1
Primary Endpoint
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2018
End Date
December 20, 2018
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Patients prescribed apixaban

Intervention: Apixaban

Patients prescribed dabigatran

Intervention: Dabigatran

Patients prescribed rivaroxaban

Intervention: Rivaroxaban

Patients prescribed warfarin

Intervention: warfarin

Patients prescribed antiplatelet

Intervention: Antiplatelets

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))

Study Sites (1)

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