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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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)). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
-≥18 years of age
Exclusion Criteria:
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Japanese patients with non-valvular atrial fibrillation and concomitant coronary artery disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim - International GmbH | Ingelheim | 55216 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38020057 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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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Every patient who fulfilled inclusion and exclusion criteria and agreed to participate in the study was selected until the required sample size was achieved.
A Real world, non-interventional cohort study based on existing data from The Medical Data Vision Co. Ltd. (Tokyo, Japan). The study aimed to make 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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2021 | Jul 12, 2023 |
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| 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. |
| FG001 | 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). |
| FG002 | 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). |
| Crude |
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| s-IPTW Adjusted | Balanced to account for potential confounding effects through an inverse probability of treatment weighting (IPTW) method |
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| COMPLETED |
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| NOT COMPLETED |
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All Eligible: patients fulfilling all inclusion criteria and no exclusion criteria (Crude)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Measure Analysis Population Description: Race and Ethnicity were not collected from any participant. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)). | 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). | Posted | Number | 95% Confidence Interval | Events per 1,000 person-years | 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. |
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| Secondary | 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. | 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). | Posted | Number | 95% Confidence Interval | Events per 1,000 person-years | 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. |
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Adverse event information was not applicable for this study.
As this is a non-interventional study with secondary use of data, safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2021 | Jul 12, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Regression, Cox |
Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios. |
| 0.0004 |
| Adjusted Hazard Ratio |
| 0.784 |
| 2-Sided |
| 95 |
| 0.686 |
| 0.896 |
Hazard ratio <1 favors Rivaroxaban. |
| Other |
| Regression, Cox | Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios. | <0.0001 | Adjusted Hazard Ratio | 0.637 | 2-Sided | 95 | 0.514 | 0.791 | Hazard ratio <1 favors Dabigatran. | Other |
| OG001 | Warfarin - Matched With Dabigatran Using the s-IPTW Method | Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection). |
| OG002 | Rivaroxaban - Matched With Warfarin Using the s-IPTW Method | Rivaroxaban - matched with Warfarin using the s-IPTW method Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection). |
| OG003 | Warfarin - Matched With Rivaroxaban Using the s-IPTW Method | Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Warfarin. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection). |
| OG004 | Dabigatran - Matched With Rivaroxaban Using the s-IPTW Method | Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Dabigatran. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection). |
| OG005 | Rivaroxaban - Matched With Dabigatran Using the s-IPTW Method | Matched cohort of patients with on-valvular atrial fibrillation (NVAF) with concomitant Coronary Artery Disease (CAD), who were prescribed with Rivaroxaban. From existing data from the Japan Medical Data Vision Co. Ltd. (MDV) database. The study period started on April 18th, 2011 (start of data collection) to December 31st, 2020 (end of data collection) |
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