Atrial FibrillationNCT02631057

Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 2 sites in Japan.

Completed

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

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Atrial Fibrillation
What is being tested?: Dabigatran and Warfarin
Type of treatment: Pill or oral medicine
How many people: 4,313 participants
Where: 2 sitesJapan
Study dates: 1 Sep 2016to 7 Sep 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Japan

Who may be able to join

1. Hospitalized patients among patients having a visit record with a confirmed diagnosis of NVAF (ICD-10 Code: I48) and prescribed dabigatran or warfarin in the hospitalization period

Who cannot join

Having a record with a diagnosis of atrial flutter, valvular atrial fibrillation or postoperative atrial fibrillation diagnosis as standard disease name during the study period.
Having a record with a diagnosis of rheumatic atrial fibrillation (ICD-10 code I05 to I09 [chronic rheumatic atrial fibrillation])or mechanical-valvular atrial fibrillation (ICD-10 code T820 [artificial cardiac valve mechanical complication]) during the study period.
Having a record with a confirmed diagnosis of cancer (ICD-10 code C00-C97 [malignant neoplasm]) during the study period.
Having a record of dialysis (class J038 artificial kidney) during the study period.
Having a record of dabigatran use for a purpose other than prevention of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients.
Having a record of dabigatran or warfarin before the hospitalization
Having a record of new diagnosis of atrial fibrillation after the initiation of dabigatran or warfarin treatment in the hospitalization period.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

1160.254.81001 Boehringer Ingelheim Investigational Site
Shinagawa City
NISED Center
Tokyo, Shinagawa, 1416017

Other trials in Japan

About this study

Official title: Comparison of the Length of Stay in Patients Hospitalized and Initiated With Dabigatran or Warfarin for a Concomitant Non-Valvular Atrial Fibrillation in Real-world Japanese Therapeutic Practice (SHORT-J)

The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world Japanese clinical practice. The secondary objective of the study is to compare LoS of patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related costs between dabigatran and warfarin, and (2) to compare the rates of patients directly discharged at home after the index hospitalization between dabigatran and warfarin.

Conditions: Atrial Fibrillation
Being tested: Dabigatran, Warfarin
Medical subject headings: Atrial Fibrillation

What participants receive

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

DabigatranDrug
Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day
WarfarinDrug
Warfarin tablet (adjustment by each patients)

Study groups in NCT02631057
Study group	Role	What they receive
Non-Valvular Atrial Fibrillation		Not described Receives: Drug: Dabigatran
acute ischemic stroke		Not described Receives: Drug: Warfarin

What is being measured

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

Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline
The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.
Measured: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.

Timeline

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

1 Sep 20167 Sep 2016

First posted15 Dec 2015 (estimated)
Study start1 Sep 2016
Primary completion7 Sep 2016
Study completion7 Sep 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: 4,313 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02631057
Sponsor's protocol ID: 1160.254
Status last verified: Aug 2017
First submitted: 8 Dec 2015
Last updated: 30 Mar 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 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Length of Stay in Patients Hospitalized and Initiated With Dabigatran or Warfarin for a Concomitant Non-Valvular Atrial Fibrillation in Real-world Japanese Therapeutic Practice (SHORT-J)
ClinicalTrials.gov ID: NCT02631057
Acronym / sponsor ID: 1160.254
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 4,313 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Sep 2016 (actual)
Primary completion: 7 Sep 2016 (actual)
Study completion: 7 Sep 2016 (actual)
First posted: 15 Dec 2015 (estimated)
Results: Posted 30 Mar 2018

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: 2

Arm	Type	Receives
Non-Valvular Atrial Fibrillation	–	Drug: Dabigatran
acute ischemic stroke	–	Drug: Warfarin

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Japan

Key inclusion criteria (1 listed)

1. Hospitalized patients among patients having a visit record with a confirmed diagnosis of NVAF (ICD-10 Code: I48) and prescribed dabigatran or warfarin in the hospitalization period

Key exclusion criteria (7 listed)

Having a record with a diagnosis of atrial flutter, valvular atrial fibrillation or postoperative atrial fibrillation diagnosis as standard disease name during the study period.
Having a record with a diagnosis of rheumatic atrial fibrillation (ICD-10 code I05 to I09 [chronic rheumatic atrial fibrillation])or mechanical-valvular atrial fibrillation (ICD-10 code T820 [artificial cardiac valve mechanical complication]) during the study period.
Having a record with a confirmed diagnosis of cancer (ICD-10 code C00-C97 [malignant neoplasm]) during the study period.
Having a record of dialysis (class J038 artificial kidney) during the study period.
Having a record of dabigatran use for a purpose other than prevention of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients.

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
DabigatranDabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day	Drug	Non-Valvular Atrial Fibrillation
WarfarinWarfarin tablet (adjustment by each patients)	Drug	acute ischemic stroke

Primary outcome

Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline
Time frame: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.
The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.

Results and safety

Results posted to the registry on 30 Mar 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 Etexilate [Prazaxa®]	899	899
Warfarin	3,414	3,414

Primary outcome: Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline

Time frame: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.. Mean (Standard Deviation). Unit: Months

Measure	Dabigatran Etexilate [Prazaxa®] n = 899	Warfarin n = 3414
Value	9.8 (13.5)	14.9 (19.4)

Dabigatran Etexilate [Prazaxa®] vs Warfarin: Mean: -2.484 (95% CI -3.717 to -1.251), p <0.001, Abadie-Imbens

Population analysed: The analysis set included patients who received the treatment Dabigatran Etexilate \[Prazaxa®\] or Warfarin.

Adverse events

Time frame: Serious and other (non-serious) adverse events were not of interest in this study and therefore were not collected or assessed as part of the study, in addition individual patient data is not available therefore adverse event data is not presented.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate [Prazaxa®]	0 of 0	0 of 0	Not reported
Warfarin	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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

2 sites 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 2 sites 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 7 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 30 Mar 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?

Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline (time frame: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.). 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 NCT02631057.

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 30 Mar 2018.