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CompletedNCT03572972Updated Apr 6, 2023Results posted

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

An observational study in Atrial Fibrillation, sponsored by Pfizer. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
64,684
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 64,684 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. Patients aged 18 years or older on the index date
  2. 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:
  3. Patients prescribed aspirin, warfarin, or NOACs during intake period (from July 1, 2015 to November 30, 2016)

Exclusion criteria

Exclusion criteria:

Patients meeting any of the following criteria will not be included in the study.

  1. Medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
  2. 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)
  3. Medical claims indicating a diagnosis code of VTE (Venous thromboembolism) during the 12-month baseline period
  4. 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)
  5. Medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (End-stage chronic kidney disease / Kidney transplant / Dialysis / Pericarditis)
  6. 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)

  7. 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
64,684 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugApixaban

    Treatment for NVAF patients

  • DrugDabigatran

    Treatment for NVAF patients

  • DrugRivaroxaban

    Treatment for NVAF patients

  • Drugwarfarin

    Treatment for NVAF patients

  • DrugAntiplatelets

    Treatment for NVAF patients

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

07

Results

Posted Feb 12, 2020
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.

Participant flow

Data was retrieved from Korean Health Insurance Review \& Assessment Service (HIRA) database, of participants who were diagnosed with non-valvular atrial fibrillation (NVAF) from 1-January-2007 up to and including index date, who newly initiated non-vitamin K antagonist oral anticoagulants (NOACs), warfarin or used aspirin during intake duration.

Participant flow — Overall Study
MilestoneNOAC - ApixabanNOAC - DabigatranNOAC - RivaroxabanWarfarinAspirin
Started105481141417779864816295
Completed105481141417779864816295
Not completed00000

Outcome measures

PrimaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis7.6613.527.213.537.1812.89
Statistical analysis
  • 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 0.884HR evaluated using extended Cox model.
PrimaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis7.757.477.357.487.017.31
Statistical analysis
  • 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
PrimaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis7.9714.738.5713.779.5514.23
Statistical analysis
  • 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 0.953HR evaluated using extended Cox model.
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.844 · 95% CI 0.685 to 1.040HR evaluated using extended Cox model.
PrimaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis7.708.657.779.868.189.36
Statistical analysis
  • 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
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis1.11.730.781.711.181.72
Statistical analysis
  • Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.673 · 95% CI 0.470 to 0.964
  • Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin) · Hazard ratio (hr): 0.491 · 95% CI 0.337 to 0.715
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.747 · 95% CI 0.548 to 1.018
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis1.110.741.051.150.711.14
Statistical analysis
  • Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran) · Hazard ratio (hr): 1.463 · 95% CI 0.998 to 2.145
  • Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.890 · 95% CI 0.647 to 1.225
  • Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.630 · 95% CI 0.447 to 0.888
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis6.911.86.5311.926.2911.19
Statistical analysis
  • Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.640 · 95% CI 0.556 to 0.738
  • Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin) · Hazard ratio (hr): 0.624 · 95% CI 0.544 to 0.715
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.749 · 95% CI 0.588 to 0.954HR evaluated using extended Cox model.
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis6.996.846.606.586.376.43
Statistical analysis
  • Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran) · Hazard ratio (hr): 0.977 · 95% CI 0.850 to 1.122
  • Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.966 · 95% CI 0.848 to 1.100
  • Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.993 · 95% CI 0.877 to 1.125
SecondaryEvent 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

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis0.180.780.240.750.270.74
Statistical analysis
  • Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.250 · 95% CI 0.119 to 0.523
  • Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin) · Hazard ratio (hr): 0.380 · 95% CI 0.203 to 0.711
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.422 · 95% CI 0.247 to 0.722
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis0.200.250.200.280.240.26
Statistical analysis
  • Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran) · Hazard ratio (hr): 0.745 · 95% CI 0.343 to 1.615
  • Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.692 · 95% CI 0.342 to 1.402
  • Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.932 · 95% CI 0.498 to 1.747
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis3.446.24.175.564.325.78
Statistical analysis
  • Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.600 · 95% CI 0.492 to 0.731
  • Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin) · Hazard ratio (hr): 1.046 · 95% CI 0.719 to 1.522HR evaluated using extended Cox model.
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 1.295 · 95% CI 0.920 to 1.824HR evaluated using extended Cox model.
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis3.234.183.284.593.974.25
Statistical analysis
  • Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran) · Hazard ratio (hr): 0.751 · 95% CI 0.62 to 0.91
  • Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.697 · 95% CI 0.586 to 0.830
  • Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.936 · 95% CI 0.801 to 1.094
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis1.372.381.172.311.472.37
Statistical analysis
  • Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.373 · 95% CI 0.212 to 0.658HR evaluated using extended Cox model.
  • Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin) · Hazard ratio (hr): 0.538 · 95% CI 0.392 to 0.737
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.664 · 95% CI 0.507 to 0.870
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis1.391.121.351.431.081.41
Statistical analysis
  • Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran) · Hazard ratio (hr): 1.204 · 95% CI 0.871 to 1.666
  • Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.918 · 95% CI 0.691 to 1.218
  • Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.771 · 95% CI 0.578 to 1.027
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
events per 100 participants-yearsApixaban vs Warfarin (Apixaban)Apixaban vs Warfarin (Warfarin)Dabigatran vs Warfarin (Dabigatran)Dabigatran vs Warfarin (Warfarin)Rivaroxaban vs Warfarin (Rivaroxaban)Rivaroxaban vs Warfarin (Warfarin)
Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis3.756.933.866.614.426.85
Statistical analysis
  • Apixaban vs Warfarin (Apixaban) vs Apixaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.581 · 95% CI 0.481 to 0.701
  • Dabigatran vs Warfarin (Dabigatran) vs Dabigatran vs Warfarin (Warfarin) · Hazard ratio (hr): 0.640 · 95% CI 0.534 to 0.766
  • Rivaroxaban vs Warfarin (Rivaroxaban) vs Rivaroxaban vs Warfarin (Warfarin) · Hazard ratio (hr): 0.838 · 95% CI 0.622 to 1.130HR evaluated using extended Cox model.
SecondaryEvent 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.

Time frame:
Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)
Reported as:
Number · events per 100 participants-years
Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
events per 100 participants-yearsApixaban vs Dabigatran (Apixaban)Apixaban vs Dabigatran (Dabigatran)Apixaban vs Rivaroxaban (Apixaban)Apixaban vs Rivaroxaban (Rivaroxaban)Dabigatran vs Rivaroxaban (Dabigatran)Dabigatran vs Rivaroxaban (Rivaroxaban)
Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis3.674.063.734.543.834.35
Statistical analysis
  • Apixaban vs Dabigatran (Apixaban) vs Apixaban vs Dabigatran (Dabigatran) · Hazard ratio (hr): 0.881 · 95% CI 0.732 to 1.061
  • Apixaban vs Rivaroxaban (Apixaban) vs Apixaban vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.802 · 95% CI 0.678 to 0.947
  • Dabigatran vs Rivaroxaban (Dabigatran) vs Dabigatran vs Rivaroxaban (Rivaroxaban) · Hazard ratio (hr): 0.882 · 95% CI 0.754 to 1.032

Adverse events

Collected over Not applicable as safety data was not planned to be collected during the study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NOAC - Apixaban———
NOAC - Dabigatran———
NOAC - Rivaroxaban———
Warfarin———
Aspirin———

Baseline characteristics

OACs treatment-naive participants diagnosed with NVAF, initiating warfarin, NOACs (apixaban, dabigatran, rivaroxaban) or aspirin treatment from 1-July-2015 to 30-November-2016.

Age, Continuous
Age, Continuous(years)NOAC - ApixabanNOAC - DabigatranNOAC - RivaroxabanWarfarinAspirinTotal
Mean73.89 ± 9.5272.23 ± 9.5273.27 ± 9.5568.73 ± 12.6272.10 ± 9.1772.29 ± 10.04
Sex: Female, Male
Sex: Female, Male(Participants)NOAC - ApixabanNOAC - DabigatranNOAC - RivaroxabanWarfarinAspirinTotal
Female5148492681693238699528476
Male5400648896105410930036208
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)NOAC - ApixabanNOAC - DabigatranNOAC - RivaroxabanWarfarinAspirinTotal
Count of participants—————0
08

Study locations

1 site
  • Korea University Hospital
    Seoul, Korea, Republic of
09

References and documents

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 ↗

Study documents

  • Study protocol · May 3, 2018
  • Statistical analysis plan · May 3, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03572972
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jun 28, 2018
Start date
Jan 31, 2018
Primary completion
Dec 20, 2018
Completion
Dec 20, 2018
Results posted
Feb 12, 2020
Last update
Apr 6, 2023

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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