Treatment Pattern of Oral Anticoagulants (OAC) in Japan

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Japan.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 48,696 participants
Where: 1 siteJapan
Study dates: 1 Dec 2016to 1 Dec 2016
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: Medical Data Vision (MDV) clinical database

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

NISED Center
Tokyo, Shinagawa, 1416017

Other trials in Japan

About this study

Official title: Treatment Patterns of Newly Initiated Oral Anticoagulants on Japanese Non-valvular Atrial Fibrillation Patients Using a Japanese Claims Database

To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database

Conditions: Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

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

Study groups in NCT02982863
Study group	Role	What they receive
All Patients		Not described

What is being measured

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

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)
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1

Secondary outcomes (8)

Baseline Characteristics: Age
Baseline characteristics of patients in each treatment group: age
Measured: 1 day
Baseline Characteristics: Gender
Baseline characteristics of patients in each treatment group: gender
Measured: Day 1
Baseline Characteristics: Year of Initiating Treatment
Baseline characteristics of patients in each treatment group: year of initiating treatment
Measured: Day 1
Baseline Characteristics: Speciality of Prescribers of OAC
Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC.
int.= internal; Med.= Medicine
Measured: Day 1
Baseline Characteristics: History of Disease
Baseline characteristics of patients in each treatment group: history of disease and hospitalization.
Measured: Day 1
Baseline Characteristics: History of Hospitalization
Baseline characteristics: history of hospitalization
Measured: Day 1
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.
Measured: Day 1
Baseline Characteristics: Concomitant Medication
Baseline characteristics of patients in each treatment group:
concomitant medication
Measured: Day 1

Timeline

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

1 Dec 20161 Dec 2016

First posted6 Dec 2016 (estimated)
Study start1 Dec 2016
Primary completion1 Dec 2016
Study completion1 Dec 2016

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.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: 48,696 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02982863
Sponsor's protocol ID: 1160-0279
Status last verified: Sep 2018
First submitted: 29 Nov 2016
Last updated: 14 Sep 2018
Results posted: Yes, on ClinicalTrials.gov

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 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Patterns of Newly Initiated Oral Anticoagulants on Japanese Non-valvular Atrial Fibrillation Patients Using a Japanese Claims Database
ClinicalTrials.gov ID: NCT02982863
Acronym / sponsor ID: 1160-0279
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 48,696 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Dec 2016 (actual)
Primary completion: 1 Dec 2016 (actual)
Study completion: 1 Dec 2016 (actual)
First posted: 6 Dec 2016 (estimated)
Results: Posted 14 Sep 2018

Clinical summary

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

To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
All Patients	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Medical Data Vision (MDV) clinical database

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

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

Primary outcome

Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF
Time frame: Day 1
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)
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
Time frame: Day 1
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.
Number of Patients Prescribed OAC Drug Warfarin by Dosage
Time frame: Day 1
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.
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
Time frame: Day 1
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.
Number of Patients Prescribed OAC Drug Apixaban by Dosage
Time frame: Day 1
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.
Number of Patients Prescribed OAC Drug Edoxaban by Dosage
Time frame: Day 1
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.

8 secondary outcomes

Baseline Characteristics: Age
Time frame: 1 day
Baseline Characteristics: Gender
Time frame: Day 1
Baseline Characteristics: Year of Initiating Treatment
Time frame: Day 1
Baseline Characteristics: Speciality of Prescribers of OAC
Time frame: Day 1
Baseline Characteristics: History of Disease
Time frame: Day 1
Baseline Characteristics: History of Hospitalization
Time frame: Day 1
Baseline Characteristics: AF Risk Score
Time frame: Day 1
Baseline Characteristics: Concomitant Medication
Time frame: Day 1

Results and safety

Results posted to the registry on 14 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran	5,745	4,936
Warfarin	16,745	12,484
Apixaban	13,238	11,386
Rivaroxaban	10,158	8,758
Edoxaban	2,760	2,268

Primary outcome: Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Dabigatran n = 5745	Warfarin n = 16745	Apixaban n = 13238	Rivaroxaban n = 10158	Edoxaban n = 2760
Value	4936	12484	11386	8758	2268

Population analysed: Patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Primary outcome: Number of Patients Prescribed OAC Drug Dabigatran by Dosage

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Dabigatran n = 4936
75 milligram (mg)	58
110 mg	164
150 mg	354
220 mg	3343
225 mg	5
300 mg	1072
440 mg	1

Population analysed: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Primary outcome: Number of Patients Prescribed OAC Drug Warfarin by Dosage

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Warfarin n = 12484
0.002 mg	2
0.006 mg	1
0.125 mg	3
0.2 mg	4
0.25 mg	338
0.3 mg	2
0.374 mg	1
0.5 mg	1726

Population analysed: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

Primary outcome: Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Rivaroxaban n = 8758
5 mg	14
7.5 mg	3
9.9 mg	3
9.99 mg	2
10 mg	4372
10.005 mg	4
10.05 mg	10
10.5 mg	1

Population analysed: eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran	0 of 0	0 of 0	Not reported
Warfarin	0 of 0	0 of 0	Not reported
Apixaban	0 of 0	0 of 0	Not reported
Rivaroxaban	0 of 0	0 of 0	Not reported
Edoxaban	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

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)

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Boehringer Ingelheim at 1 site in Japan.

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 1 inclusion and 1 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 14 Sep 2018. 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 Japan. 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 14 Sep 2018). 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?

Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF (time frame: Day 1). The study lists 6 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 NCT02982863.

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 14 Sep 2018.