Medical Need of OAC Reversal

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

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: warfarin, dabigatran and Apixaban
Type of treatment: Pill or oral medicine
How many people: 53,969 participants
Where: 1 siteJapan
Study dates: 15 Oct 2017to 10 Nov 2017
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: Any patients with atrial fibrillation contained in the Medical Data Vision (MDV) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.

Who may be able to join

->18 year old non-valvular atrial fibrillation (NVAF) patients
Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
Patients with confirmed date of initiation of OACs
Patients with a minimum of 6 months of enrolment data prior to index date
Has an index date between 14th of March 2011 to 30 June, 2016

Who cannot join

Patients receiving two or more oral anti-coagulants at the same time at index date
Patients with prescriptions of index treatment in the 6 months prior to index date
Patients without enrolment period of at least six month in the database

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd.
Tokyo

Other trials in Japan

About this study

Official title: Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the Study Number Begins With 1321; the Study Contains Only Patients Treated With OACs, Namely Warfarin, Dabigatran, Edoxaban, Apixaban, Rivaroxaban, Edoxaban)

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

Read the detailed description

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF, the incidence rates of emergency surgery, major bleeding due to trauma, and major bleeding due to fracture, overall and stratified by age (<64, 65-74, >75). The secondary objective is to estimate the overall and age stratified incidence of cardiac tamponade and peri-cardiocentesis.

Conditions: Atrial Fibrillation
Being tested: warfarin, dabigatran, Apixaban, Edoxaban, Rivaroxaban
Medical subject headings: Atrial Fibrillation

What participants receive

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

warfarinDrug
warfarin
dabigatranDrug
Also called PRADAXA, PRAZAXA
Non-vitamin K dependent oral anti-coagulants (NOACs)
ApixabanDrug
Non-vitamin K dependent oral anti-coagulants (NOACs)
EdoxabanDrug
Non-vitamin K dependent oral anti-coagulants (NOACs)
RivaroxabanDrug
Non-vitamin K dependent oral anti-coagulants (NOACs)

Study groups in NCT03254147
Study group	Role	What they receive
patients prescribed with Oral Anti-coagulants		warfarin and non-vitamin K dependent oral anti-coagulants Receives: Drug: warfarin; Drug: dabigatran; Drug: Apixaban; Drug: Edoxaban; Drug: Rivaroxaban

What is being measured

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

The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.
Measured: One year

Secondary outcomes (1)

The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.
Measured: One year

Timeline

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

15 Oct 201710 Nov 2017

First posted18 Aug 2017
Study start15 Oct 2017
Primary completion30 Oct 2017
Study completion10 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by 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: 53,969 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254147
Sponsor's protocol ID: 1321-0022
Status last verified: Oct 2018
First submitted: 17 Aug 2017
Last updated: 4 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Yasaka M, Yokota H, Suzuki M, Yamane T, Ono Y. Incidence Rates of Bleeding and Emergency Surgery Due to Trauma or Fracture Among Japanese Patients with Non-valvular Atrial Fibrillation Receiving Oral Anticoagulation Therapy. Cardiol Ther. 2020 Jun;9(1):189-199. doi: 10.1007/s40119-020-00171-w. Epub 2020 May 11.
PubMed 32394292

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 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the Study Number Begins With 1321; the Study Contains Only Patients Treated With OACs, Namely Warfarin, Dabigatran, Edoxaban, Apixaban, Rivaroxaban, Edoxaban)
ClinicalTrials.gov ID: NCT03254147
Acronym / sponsor ID: 1321-0022
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 53,969 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Oct 2017 (actual)
Primary completion: 30 Oct 2017 (actual)
Study completion: 10 Nov 2017 (actual)
First posted: 18 Aug 2017 (actual)
Results: Posted 4 Mar 2019

Clinical summary

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

This is a retrospective, observational, claims cohort study to assess, for adult patients initiating an oral anticoagulant for NVAF

Detailed description

Study design

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

Arm	Type	Receives
patients prescribed with Oral Anti-coagulants	–	Drug: warfarin, Drug: dabigatran, Drug: Apixaban, Drug: Edoxaban, Drug: Rivaroxabanwarfarin and non-vitamin K dependent oral anti-coagulants

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Any patients with atrial fibrillation contained in the Medical Data Vision (MDV) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.

Key inclusion criteria (5 listed)

->18 year old non-valvular atrial fibrillation (NVAF) patients
Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin
Patients with confirmed date of initiation of OACs
Patients with a minimum of 6 months of enrolment data prior to index date
Has an index date between 14th of March 2011 to 30 June, 2016

Key exclusion criteria (3 listed)

Patients receiving two or more oral anti-coagulants at the same time at index date
Patients with prescriptions of index treatment in the 6 months prior to index date
Patients without enrolment period of at least six month in the database

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
warfarinwarfarin	Drug	patients prescribed with Oral Anti-coagulants
dabigatranAlso: PRADAXA, PRAZAXANon-vitamin K dependent oral anti-coagulants (NOACs)	Drug	patients prescribed with Oral Anti-coagulants
ApixabanNon-vitamin K dependent oral anti-coagulants (NOACs)	Drug	patients prescribed with Oral Anti-coagulants
EdoxabanNon-vitamin K dependent oral anti-coagulants (NOACs)	Drug	patients prescribed with Oral Anti-coagulants
RivaroxabanNon-vitamin K dependent oral anti-coagulants (NOACs)	Drug	patients prescribed with Oral Anti-coagulants

Primary outcome

The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
Time frame: One year
The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.

1 secondary outcome

The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
Time frame: One year

Results and safety

Results posted to the registry on 4 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Prescribed With Non-warfarin Oral Anti Coagulants	53,969	53,969

Primary outcome: The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.

Time frame: One year. Number. Unit: Number of Patients

Measure	Patients Prescribed With Non-warfarin Oral Anti Coagulants n = 53969
Age <=64	14
Age 65-74	35
Age >=75	84

Population analysed: Results are based on the number of patients meeting the inclusion and exclusion criteria.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: No adverse event reporting was done.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Prescribed With Non-warfarin Oral Anti Coagulants	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The findings from this study may not be generalizable to other Japanese population outside of Diagnosis Procedure Combination (DPC) hospitals. All information of each patient is from consent giving DPC hospitals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32394292Yasaka M, Yokota H, Suzuki M, Yamane T, Ono Y. Incidence Rates of Bleeding and Emergency Surgery Due to Trauma or Fracture Among Japanese Patients with Non-valvular Atrial Fibrillation Receiving Oral Anticoagulation Therapy. Cardiol Ther. 2020 Jun;9(1):189-199. doi: 10.1007/s40119-020-00171-w. Epub 2020 May 11.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

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 5 inclusion and 3 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 4 Mar 2019. 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 4 Mar 2019). 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?

The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma. (time frame: One year). 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 NCT03254147, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.