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CompletedNCT02982863Updated Sep 14, 2018Results posted

Treatment Pattern of Oral Anticoagulants (OAC) in Japan

An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-14.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
48,696
Ages
18 Years and older
Sex
All
01

Study summary

  1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
  2. To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
  3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in 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 48,696 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) 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
Non-probability sample

Study population

Medical Data Vision (MDV) clinical database

Inclusion criteria

  • Patients aged >18 year-old with confirmed diagnosis of NVAF (ICD 10 code I48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other OACs for12 months prior to the index date (defined as the first prescription of OACs (the period is defined as baseline period)), and having an index date between 14 Mar 2011 to 30 June 2016

Exclusion criteria

Exclusion criteria:

  • Patients having less than 12 months of enrolment prior to the index date , being dialysis or kidney transplant recipients in baseline period, having either atrial flutter, valvular AF, mechanical valve placement, rheumatic AF, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism \< 6 months before Atrial Fibrillation (AF) diagnosis in baseline period
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
48,696 participants (actual)
Patient registry
No

Groups and cohorts

  • All Patients
06

What researchers measure

Primary outcomes

  1. Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF

    Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF)

    Time frame: Day 1

  2. Number of Patients Prescribed OAC Drug Dabigatran by Dosage

    Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

    Time frame: Day 1

  3. Number of Patients Prescribed OAC Drug Warfarin by Dosage

    Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

    Time frame: Day 1

  4. Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage

    Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

    Time frame: Day 1

  5. Number of Patients Prescribed OAC Drug Apixaban by Dosage

    Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

    Time frame: Day 1

  6. Number of Patients Prescribed OAC Drug Edoxaban by Dosage

    Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

    Time frame: Day 1

Secondary outcomes

  1. Baseline Characteristics: Age

    Baseline characteristics of patients in each treatment group: age

    Time frame: 1 day

  2. Baseline Characteristics: Gender

    Baseline characteristics of patients in each treatment group: gender

    Time frame: Day 1

  3. Baseline Characteristics: Year of Initiating Treatment

    Baseline characteristics of patients in each treatment group: year of initiating treatment

    Time frame: Day 1

  4. Baseline Characteristics: Speciality of Prescribers of OAC

    Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine

    Time frame: Day 1

  5. Baseline Characteristics: History of Disease

    Baseline characteristics of patients in each treatment group: history of disease and hospitalization.

    Time frame: Day 1

  6. Baseline Characteristics: History of Hospitalization

    Baseline characteristics: history of hospitalization

    Time frame: Day 1

  7. Baseline Characteristics: AF Risk Score

    Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk.

    Time frame: Day 1

  8. Baseline Characteristics: Concomitant Medication

    Baseline characteristics of patients in each treatment group: concomitant medication

    Time frame: Day 1

07

Results

Posted Sep 14, 2018
Limitations and caveats
Generalizability of findings may be limited outside of population. The data in Medical Data Vision Co., Ltd. (MDV) database is collected from DPC hospitals that may contain out-patient data with greater disease severity.

Participant flow

A retrospective, observational study using health insurance claims data.48696 patients were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs but 50 patients were removed as they took more than one these drugs. Thus only 48646 patients were prescribed the drugs of interest.

Participant flow — Overall Study
MilestoneDabigatranWarfarinApixabanRivaroxabanEdoxaban
Started57451674513238101582760
Completed4936124841138687582268
Not completed809426118521400492
Withdrew: Not eligible patients809426118521400492

Outcome measures

PrimaryNumber of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF

Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF)

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF4936124841138687582268
PrimaryNumber of Patients Prescribed OAC Drug Dabigatran by Dosage

Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
ParticipantsDabigatran
75 milligram (mg)58
110 mg164
150 mg354
220 mg3343
225 mg5
300 mg1072
440 mg1
PrimaryNumber of Patients Prescribed OAC Drug Warfarin by Dosage

Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Patients Prescribed OAC Drug Warfarin by Dosage
ParticipantsWarfarin
0.002 mg2
0.006 mg1
0.125 mg3
0.2 mg4
0.25 mg338
0.3 mg2
0.374 mg1
0.5 mg1726
0.6 mg3
0.625 mg2
0.65 mg1
0.7 mg1
0.75 mg256
0.8 mg1
0.875 mg3
0.9 mg2
1 mg3125
1.2 mg2
1.25 mg62
1.3 mg1
1.5 mg630
1.55 mg1
1.7 mg2
1.75 mg66
1.8 mg2
1.9 mg1
2 mg4711
2.2 mg1
2.25 mg54
2.3 mg1
2.4 mg3
2.5 mg462
2.7 mg1
2.75 mg24
3 mg1913
3.2 mg1
3.25 mg17
3.3 mg1
3.5 mg128
3.7 mg1
3.75 mg9
4 mg421
4.25 mg3
4.5 mg41
4.6 mg1
4.75 mg1
5 mg468
5.5 mg9
6 mg25
6.5 mg2
7 mg8
7.75 mg1
8 mg3
9 mg1
10 mg16
17.5 mg1
20 mg3
30 mg12
40 mg3
50 mg1
PrimaryNumber of Patients Prescribed OAC Drug Rivaroxaban by Dosage

Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
ParticipantsRivaroxaban
5 mg14
7.5 mg3
9.9 mg3
9.99 mg2
10 mg4372
10.005 mg4
10.05 mg10
10.5 mg1
15 mg4340
20 mg5
22.5 mg1
30 mg72
PrimaryNumber of Patients Prescribed OAC Drug Apixaban by Dosage

Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Patients Prescribed OAC Drug Apixaban by Dosage
ParticipantsApixaban
1.25 mg2
2.5 mg428
3.75 mg2
5 mg6300
7.5 mg1
10 mg4789
15 mg1
20 mg27
25 mg2
35 mg1
PrimaryNumber of Patients Prescribed OAC Drug Edoxaban by Dosage

Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Number of Patients Prescribed OAC Drug Edoxaban by Dosage
ParticipantsEdoxaban
15 mg279
30 mg1594
60 mg412
SecondaryBaseline Characteristics: Age

Baseline characteristics of patients in each treatment group: age

Time frame:
1 day
Reported as:
Mean · Years
Baseline Characteristics: Age
YearsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Baseline Characteristics: Age72 ± 1078 ± 1077 ± 1074 ± 1177 ± 10
SecondaryBaseline Characteristics: Gender

Baseline characteristics of patients in each treatment group: gender

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: Gender
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Female16255068473731831130
Male33117416664955751138
SecondaryBaseline Characteristics: Year of Initiating Treatment

Baseline characteristics of patients in each treatment group: year of initiating treatment

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: Year of Initiating Treatment
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
2011/3/14-2012/2/294041138008
2012/3/1-2013/2/2812592002017532
2013/3/1-2014/2/2810812292188186829
2014/3/1-2015/2/281019280834552182158
2015/3/1-2016/2/299193217563433021289
2016/3/1-2016/6/30254102721091231752
SecondaryBaseline Characteristics: Speciality of Prescribers of OAC

Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: Speciality of Prescribers of OAC
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Internal medicine1689431639432816654
Psychodiagnosis medical23211
Psychiatry93830207
Neurology01732
Respiratory66180957217
Gastroenterology10628310012526
Cardiology1457244726102268465
Allergy19100
Rheumatology711632
Pediatrics05440
Surgery10951420217552
Orthopedics113550212178317
Plastic surgery5211052
Cranial nerve surgery319668932654164
Thoracic surgery105827253
Cardiovascular surgery8740511514754
Pediatric surgery00100
Obstetrics and gynecology411956
Ophthalmology193826365
Otorhinolaryngology84725195
Rehabilitation30127868612
Radiology412850
Neuropathic internal medicine21041051841574
Gastrointestinal017531
Dermatology94123233
Urology31161765515
Gynecology22120
Respiratory medicine361611127518
Cardiovascular internal medicine444125819301218301
Diabetes3148100
Nephrology138527157
Hemodialysis18000
Metabolism internal medicine03470
Endocrinology82416152
Emergency medicine1859544611
Gastroenterological medicine53270618520
Digestive surgery6257104
Hepato-biliarypancreatic surgery04411
Diabetes medicine4191290
Large intestine and proctology01000
Connective tissue disease & iheumatic int. med.28110
Stroke26500
Oncotherapy26011
Comprehensive medical care13561293
Breast and thyroid surgery03021
Pediatric cardiology03000
Palliative care01000
Hematology & medical Oncology01111
Psychiatry & neurology00100
Endocrinology & metabolism11210
Unknown275938838
Hematology62711202
Anesthesiology07641
SecondaryBaseline Characteristics: History of Disease

Baseline characteristics of patients in each treatment group: history of disease and hospitalization.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: History of Disease
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Stroke or transient ischemic attack631451288521
Myocardial infarction317903890629178
Coronary artery disease3987795325
Heart failure1899675050993580977
Diabetes mellitus1979480442553324841
Dyslipidemia1366288831092402597
Arterial hypertension29388501699053571344
Peripheral artery disease58015381290933252
Peptic ulcer disease958230121481558452
Dementia10744734826890
Malignant lymphoma6217115910941
Leukemia341611078227
Solid tumor cancer1501383034132524678
Kidney impairment199697527360118
Liver disease784177715761257339
Valvular disease1659429429612561615
Bleeding (gastrointestinal, etc.)1619386735672677782
SecondaryBaseline Characteristics: History of Hospitalization

Baseline characteristics: history of hospitalization

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: History of Hospitalization
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Baseline Characteristics: History of Hospitalization23849494651745891412
SecondaryBaseline Characteristics: AF Risk Score

Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk.

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: AF Risk Score
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
0 (CHADS2)70775011501072238
1 (CHADS2)1103223925041928513
2 (CHADS2)1131281623302022517
3 (CHADS2)1053345827872005523
4 (CHADS2)582189716111014267
5 (CHADS2)243816626459125
6 (CHADS2)11750837825885
0 (CHA2DS2VASc)19818228029566
1 (CHA2DS2VASc)547585773783140
2 (CHA2DS2VASc)878150016921481305
3 (CHA2DS2VASc)968238022131735497
4 (CHA2DS2VASc)916268522161718432
5 (CHA2DS2VASc)690249620701348380
6 (CHA2DS2VASc)44114821165769241
7 (CHA2DS2VASc)188738644402129
8 (CHA2DS2VASc)9636925718861
9 (CHA2DS2VASc)1467763917
0 (HAS-BLED)29724542243268
1 (HAS-BLED)1276230328482228545
2 (HAS-BLED)1616418037252884746
3 (HAS-BLED)1192373828372159590
4 (HAS-BLED)45815621258872270
5 (HAS-BLED)8940326616246
6 (HAS-BLED)75330203
7 (HAS-BLED)10010
8 (HAS-BLED)00000
SecondaryBaseline Characteristics: Concomitant Medication

Baseline characteristics of patients in each treatment group: concomitant medication

Time frame:
Day 1
Reported as:
Count of participants · Participants
Baseline Characteristics: Concomitant Medication
ParticipantsDabigatranWarfarinApixabanRivaroxabanEdoxaban
Aspirin989284820271621377
Ticlodipine691791159512
Cilostazole19952246630666
Clopidogrel34610491031767153
ARB or ACE1649477336502954661
Beta blocker1779437642723137768
Amiodarone6238830113831
Procainamide144043178
Disopyramide10223018015034
Flecainide13010523715033
Pilsicainide582726970885145
Calcium channel blockers (CCB)2176575551483955955
Digoxin5061959944896134
Diuretics1277590136982480681
Statins1029273623641876407
Proton pump inhibitor1869551245833506970
H2 receptor antagonist761255916731365367

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dabigatran———
Warfarin———
Apixaban———
Rivaroxaban———
Edoxaban———

Baseline characteristics

Eligible patient who were prescribed dabigatran, warfarin, apixaban, or edoxaban as the first OACs

Age, Continuous
Age, Continuous(Years)DabigatranWarfarinApixabanRivaroxabanEdoxabanTotal
Mean72 ± 1078 ± 1077 ± 1074 ± 1177 ± 1076 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)DabigatranWarfarinApixabanRivaroxabanEdoxabanTotal
Female1625506847373183113015743
Male3311741666495575113824089
08

Study locations

1 site
  • NISED Center
    Tokyo, Shinagawa, 1416017, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02982863
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Dec 6, 2016
Start date
Dec 1, 2016
Primary completion
Dec 1, 2016
Completion
Dec 1, 2016
Results posted
Sep 14, 2018
Last update
Sep 14, 2018

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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