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

An observational study of Atrial Fibrillation, run by Pfizer at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Apixaban, Dabigatran and Rivaroxaban
How many people: 64,684 participants
Where: 1 siteSouth Korea
Study dates: 31 Jan 2018to 20 Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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)

Who cannot join

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)

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Korea University Hospital
Seoul

Other trials in South Korea

About this study

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

Conditions: Atrial Fibrillation
Being tested: Apixaban, Dabigatran, Rivaroxaban, warfarin, Antiplatelets
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApixabanDrug
Treatment for NVAF patients
DabigatranDrug
Treatment for NVAF patients
RivaroxabanDrug
Treatment for NVAF patients
warfarinDrug
Treatment for NVAF patients
AntiplateletsDrug
Treatment for NVAF patients

Study groups in NCT03572972
Study group	Role	What they receive
Patients prescribed apixaban		Not described Receives: Drug: Apixaban
Patients prescribed dabigatran		Not described Receives: Drug: Dabigatran
Patients prescribed rivaroxaban		Not described Receives: Drug: Rivaroxaban
Patients prescribed warfarin		Not described Receives: Drug: warfarin
Patients prescribed antiplatelet		Not described Receives: Drug: Antiplatelets

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. 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.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. 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.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. 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
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (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). 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.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (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). Index date = the first prescription date of study drugs during intake duration.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. 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.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). 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.
Measured: 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
Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration.
Measured: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 201820 Dec 2018

First posted28 Jun 2018
Study start31 Jan 2018
Primary completion20 Dec 2018
Study completion20 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 64,684 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03572972
Sponsor's protocol ID: X9001134
Status last verified: Feb 2020
First submitted: 19 Jun 2018
Last updated: 6 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

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.
PubMed 35524839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA
ClinicalTrials.gov ID: NCT03572972
Acronym / sponsor ID: X9001134
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 64,684 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 31 Jan 2018 (actual)
Primary completion: 20 Dec 2018 (actual)
Study completion: 20 Dec 2018 (actual)
First posted: 28 Jun 2018 (actual)
Results: Posted 12 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ApixabanTreatment for NVAF patients	Drug	Patients prescribed apixaban
DabigatranTreatment for NVAF patients	Drug	Patients prescribed dabigatran
RivaroxabanTreatment for NVAF patients	Drug	Patients prescribed rivaroxaban
warfarinTreatment for NVAF patients	Drug	Patients prescribed warfarin
AntiplateletsTreatment for NVAF patients	Drug	Patients prescribed antiplatelet

Primary outcome

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 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.
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.

12 secondary outcomes

Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Results and safety

Results posted to the registry on 12 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NOAC - Apixaban	10,548	10,548
NOAC - Dabigatran	11,414	11,414
NOAC - Rivaroxaban	17,779	17,779
Warfarin	8,648	8,648
Aspirin	16,295	16,295

Primary outcome: 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). Number. Unit: events per 100 participants-years

Measure	Apixaban vs Warfarin (Apixaban) n = 10514	Apixaban vs Warfarin (Warfarin) n = 8677	Dabigatran vs Warfarin (Dabigatran) n = 11415	Dabigatran vs Warfarin (Warfarin) n = 8676	Rivaroxaban vs Warfarin (Rivaroxaban) n = 17780	Rivaroxaban vs Warfarin (Warfarin) n = 8638
Value	7.66	13.52	7.2	13.53	7.18	12.89

Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin): Hazard Ratio (HR): 0.618 (95% CI 0.541 to 0.707)
Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin): Hazard Ratio (HR): 0.604 (95% CI 0.530 to 0.687)
Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin): Hazard Ratio (HR): 0.705 (95% CI 0.563 to 0.884)

Population analysed: OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.

Primary outcome: 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). Number. Unit: events per 100 participants-years

Measure	Apixaban vs Dabigatran (Apixaban) n = 10567	Apixaban vs Dabigatran (Dabigatran) n = 11415	Apixaban vs Rivaroxaban (Apixaban) n = 10545	Apixaban vs Rivaroxaban (Rivaroxaban) n = 17812	Dabigatran vs Rivaroxaban (Dabigatran) n = 11416	Dabigatran vs Rivaroxaban (Rivaroxaban) n = 17801
Value	7.75	7.47	7.35	7.48	7.01	7.31

Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran): Hazard Ratio (HR): 0.993 (95% CI 0.870 to 1.134)
Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban): Hazard Ratio (HR): 0.949 (95% CI 0.839 to 1.073)
Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban): Hazard Ratio (HR): 0.961 (95% CI 0.854 to 1.082)

Primary outcome: 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). Number. Unit: events per 100 participants-years

Measure	Apixaban vs Warfarin (Apixaban) n = 10514	Apixaban vs Warfarin (Warfarin) n = 8677	Dabigatran vs Warfarin (Dabigatran) n = 11415	Dabigatran vs Warfarin (Warfarin) n = 8676	Rivaroxaban vs Warfarin (Rivaroxaban) n = 17780	Rivaroxaban vs Warfarin (Warfarin) n = 8638
Value	7.97	14.73	8.57	13.77	9.55	14.23

Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin): Hazard Ratio (HR): 0.583 (95% CI 0.512 to 0.664)
Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin): Hazard Ratio (HR): 0.754 (95% CI 0.597 to 0.953)
Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin): Hazard Ratio (HR): 0.844 (95% CI 0.685 to 1.040)

Primary outcome: 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). Number. Unit: events per 100 participants-years

Measure	Apixaban vs Dabigatran (Apixaban) n = 10567	Apixaban vs Dabigatran (Dabigatran) n = 11415	Apixaban vs Rivaroxaban (Apixaban) n = 10545	Apixaban vs Rivaroxaban (Rivaroxaban) n = 17812	Dabigatran vs Rivaroxaban (Dabigatran) n = 11416	Dabigatran vs Rivaroxaban (Rivaroxaban) n = 17801
Value	7.70	8.65	7.77	9.86	8.18	9.36

Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran): Hazard Ratio (HR): 0.866 (95% CI 0.761 to 0.985)
Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban): Hazard Ratio (HR): 0.768 (95% CI 0.684 to 0.862)
Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban): Hazard Ratio (HR): 0.875 (95% CI 0.786 to 0.975)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable as safety data was not planned to be collected during the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
NOAC - Apixaban	0 of 0	0 of 0
NOAC - Dabigatran	0 of 0	0 of 0
NOAC - Rivaroxaban	0 of 0	0 of 0
Warfarin	0 of 0	0 of 0
Aspirin	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35524839Lee 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Pfizer at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03572972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.