Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

NCT03572972 | Completed Results FDA Drug

• 1 other identifier: X9001134
• Study Type: observational
• Target: 64,684
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

  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.

  Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

• Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

  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.

  Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

• Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

  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.

  Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

• Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

  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.

  Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Secondary Outcomes (12)

• 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 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 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 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 Warfarin Analysis

  Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Study Arms (5)

Patients prescribed apixaban

Drug: Apixaban

Patients prescribed dabigatran

Drug: Dabigatran

Patients prescribed rivaroxaban

Drug: Rivaroxaban

Patients prescribed warfarin

Drug: warfarin

Patients prescribed antiplatelet

Drug: Antiplatelets

Interventions

Apixaban DRUG

Treatment for NVAF patients

Patients prescribed apixaban

Dabigatran DRUG

Treatment for NVAF patients

Patients prescribed dabigatran

Rivaroxaban DRUG

Treatment for NVAF patients

Patients prescribed rivaroxaban

warfarin DRUG

Treatment for NVAF patients

Patients prescribed warfarin

Antiplatelets DRUG

Treatment for NVAF patients

Patients prescribed antiplatelet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be selected from Korean Health Insurance Review \& Assessment Service (HIRA) database according to the inclusion/exclusion criteria. Only users of oral anticoagulant or antiplatelet treatment for atrial fibrillation from July 1, 2015 to November 30, 2016 will be included in this study.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Korea University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Lee MY, Han S, Bang OY, On YK, Jang SW, Han S, Ryu J, Park YJ, Kang S, Suh HS, Kim YH. Drug Utilization Pattern of Oral Anticoagulants in Patients with Atrial Fibrillation: A Nationwide Population-Based Study in Korea. Adv Ther. 2022 Jul;39(7):3112-3130. doi: 10.1007/s12325-022-02151-z. Epub 2022 May 7.

  PMID: 35524839 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixaban; Dabigatran; Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Limitations and Caveats

Data for Aspirin group could not be matched with other treatment groups (because of genuine difference and heterogeneity in their characteristics) using IPTW method. Hence, no data for Aspirin reporting arm is reported in outcome measures.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: January 31, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: April 6, 2023
• Results First Posted: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)