Coronary Artery DiseaseNCT05051904

A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin

An observational study of Coronary Artery Disease and Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Germany.

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

The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Atrial Fibrillation
How many people: 39,357 participants
Where: 1 siteGermany
Study dates: 17 May 2022to 29 Jul 2022
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: Japanese patients with non-valvular atrial fibrillation and concomitant coronary artery disease

Who may be able to join

-≥18 years of age
Has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period)
New users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period
Has at least 1 diagnosis of NVAF during the look-back period prior to or on the index date
Has at least 1 diagnosis of CAD during the look-back period prior to or on the index date

Who cannot join

Diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period
Initiate warfarin, dabigatran, rivaroxaban due to valvular Atrial Fibrillation (AF), AF associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic AF
Underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date
Prescribed with more than 1 oral anticoagulation (OAC) on the index date
Prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection
Patients with missing or ambiguous age or sex information

Trial locations and contacts

1 site in 1 country.

Germany1 site

Boehringer Ingelheim - International GmbH
Ingelheim, 55216

Other trials in Germany

About this study

Official title: Comparative Safety and Effectiveness of Warfarin, Dabigatran, and Rivaroxaban Among Japanese Patients With Non-valvular Atrial Fibrillation (NVAF) and Concomitant Coronary Artery Disease (CAD)

Conditions: Coronary Artery Disease, Atrial Fibrillation
Medical subject headings: Coronary Artery Disease, Atrial Fibrillation

What participants receive

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

Study groups in NCT05051904
Study group	Role	What they receive
Warfarin		All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).
Dabigatran		All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).
Rivaroxaban		All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

What is being measured

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

Incidence Rate of Fatal or Non-fatal Major Bleeding
Incidence rate of fatal or non-fatal major bleeding per number of person-years, defined as any blood transfusion and/or any hospitalization with associated bleeding in all three patient groups. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000*person-years)).
Measured: From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.

Secondary outcomes (1)

Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH
Incidence rate of the Composite outcome of stroke/SE/MI/all-cause mortality (inpatient) /major bleeding/major GI bleeding (hospitalization due to gastrointestinal bleeding)/ICH (Intracraneal hemorrhage) per number of person-years. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000*person-years)). The propensity scores were estimated using the multivariable logistic regression model. Statistical analysis for comparisons: Dabigatran-Warfarin, and Rivaroxaban-Warfarin are presented as per protocol.
Measured: From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.

Timeline

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

17 May 202229 Jul 2022

First posted21 Sep 2021
Study start17 May 2022
Primary completion29 Jul 2022
Study completion29 Jul 2022

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 Coronary Artery DiseaseStudies 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: 39,357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05051904
Sponsor's protocol ID: 1160-0308
Status last verified: Jul 2023
First submitted: 15 Sep 2021
Last updated: 7 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

Chen Y, Gong X, Bao H. Real-world clinical outcomes of oral anticoagulants among Japanese patients with atrial fibrillation and concomitant coronary artery disease. Int J Cardiol Heart Vasc. 2023 Nov 2;49:101285. doi: 10.1016/j.ijcha.2023.101285. eCollection 2023 Dec.
PubMed 38020057

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

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Safety and Effectiveness of Warfarin, Dabigatran, and Rivaroxaban Among Japanese Patients With Non-valvular Atrial Fibrillation (NVAF) and Concomitant Coronary Artery Disease (CAD)
ClinicalTrials.gov ID: NCT05051904
Acronym / sponsor ID: 1160-0308
Conditions: Coronary Artery Disease, Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 39,357 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 17 May 2022 (actual)
Primary completion: 29 Jul 2022 (actual)
Study completion: 29 Jul 2022 (actual)
First posted: 21 Sep 2021 (actual)
Results: Posted 7 Mar 2024

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: 3

Arm	Type	Receives
Warfarin	–	–All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).
Dabigatran	–	–All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).
Rivaroxaban	–	–All eligible Japanese on-valvular atrial fibrillation (NVAF) patients with concomitant Coronary Artery Disease (CAD), who were prescribed with rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database, which covered all insurance types and a large population size. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Japanese patients with non-valvular atrial fibrillation and concomitant coronary artery disease

Key inclusion criteria (5 listed)

-≥18 years of age
Has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period)
New users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period
Has at least 1 diagnosis of NVAF during the look-back period prior to or on the index date
Has at least 1 diagnosis of CAD during the look-back period prior to or on the index date

Key exclusion criteria (6 listed)

Diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period
Initiate warfarin, dabigatran, rivaroxaban due to valvular Atrial Fibrillation (AF), AF associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic AF
Underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date
Prescribed with more than 1 oral anticoagulation (OAC) on the index date
Prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection

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

Incidence Rate of Fatal or Non-fatal Major Bleeding
Time frame: From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.
Incidence rate of fatal or non-fatal major bleeding per number of person-years, defined as any blood transfusion and/or any hospitalization with associated bleeding in all three patient groups. The incidence rate was reported as the number of events (counts the first event per patient) divided by the total number of person-years at risk during follow-up (1/(1000*person-years)).

1 secondary outcome

Incidence Rate of Composite Outcome of Stroke/SE/MI/All-cause Mortality (Inpatient) /Major Bleeding/Major GI Bleeding/ICH
Time frame: From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.

Results and safety

Results posted to the registry on 7 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Warfarin	12,316	12,316
Dabigatran	6,712	6,712
Rivaroxaban	20,329	20,329

Primary outcome: Incidence Rate of Fatal or Non-fatal Major Bleeding

Time frame: From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.. Number (95% Confidence Interval). Unit: Events per 1,000 person-years

Measure	Dabigatran - Matched With Warfarin Using the s-IPTW Method n = 6682	Warfarin - Matched With Dabigatran Using the s-IPTW Method n = 12231	Rivaroxaban - Matched With Warfarin Using the s-IPTW Method n = 20422	Warfarin - Matched With Rivaroxaban Using the s-IPTW Method n = 12231	Dabigatran - Matched With Rivaroxaban Using the s-IPTW Method n = 6682	Rivaroxaban - Matched With Dabigatran Using the s-IPTW Method n = 20422
Value	26 (22 to 31)	52 (47 to 57)	41 (38 to 44)	52 (47 to 57)	26 (22 to 31)	41 (38 to 44)

Dabigatran - Matched With Warfarin Using the s-IPTW Method vs Warfarin - Matched With Dabigatran Using the s-IPTW Method: Adjusted Hazard Ratio: 0.5 (95% CI 0.402 to 0.622), p <0.0001, Regression, Cox
Rivaroxaban - Matched With Warfarin Using the s-IPTW Method vs Warfarin - Matched With Rivaroxaban Using the s-IPTW Method: Adjusted Hazard Ratio: 0.784 (95% CI 0.686 to 0.896), p = 0.0004, Regression, Cox
Dabigatran - Matched With Rivaroxaban Using the s-IPTW Method vs Rivaroxaban - Matched With Dabigatran Using the s-IPTW Method: Adjusted Hazard Ratio: 0.637 (95% CI 0.514 to 0.791), p <0.0001, Regression, Cox

Population analysed: Matched cohort of initiators of Dabigatran, Warfarin, Rivaroxaban using the inverse probability of treatment weighting (IPTW) method, identified from the Japan Medical Data Vision Co. Ltd. (MDV) database on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Warfarin	0 of 0	0 of 0
Dabigatran	0 of 0	0 of 0
Rivaroxaban	0 of 0	0 of 0

Limitations and caveats (from the sponsor): This was a Non interventional study (NIS) based on existing data. Therefore, the study might be subject to potential residual confounding due to the absence of certain key data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38020057Chen Y, Gong X, Bao H. Real-world clinical outcomes of oral anticoagulants among Japanese patients with atrial fibrillation and concomitant coronary artery disease. Int J Cardiol Heart Vasc. 2023 Nov 2;49:101285. doi: 10.1016/j.ijcha.2023.101285. eCollection 2023 Dec.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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 Coronary Artery Disease and Atrial Fibrillation, run by Boehringer Ingelheim at 1 site in Germany.

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 6 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 7 Mar 2024. 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 Germany. 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 7 Mar 2024). 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?

Incidence Rate of Fatal or Non-fatal Major Bleeding (time frame: From the cohort entry date (first prescription of the drug of interest) to the earliest occurrence of the event (discontinuation of drug of interest, switching to another Oral Anticoagulation, loss of follow-up, death, end of the study). Up to 9 years.). 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 NCT05051904, 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 7 Mar 2024.