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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Valvular Atrial Fibrillation |
| ||
| acute ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the date of index treatment until the date of discharge from hospital, assessed upto 60 months. |
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Inclusion criteria:
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
Exclusion criteria:
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Japan
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.254.81001 Boehringer Ingelheim Investigational Site | Shinagawa City | Japan | ||||
| NISED Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate [Prazaxa®] | The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). |
| FG001 | Warfarin | Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The analysis set included patients who received the treatment Dabigatran Etexilate [Prazaxa®] or Warfarin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate [Prazaxa®] | The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). |
| BG001 | Warfarin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | The analysis set included patients who received the treatment Dabigatran Etexilate [Prazaxa®] or Warfarin. | Posted | Mean | Standard Deviation | Months | From the date of index treatment until the date of discharge from hospital, assessed upto 60 months. |
|
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.
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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 | Dabigatran Etexilate [Prazaxa®] | The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Warfarin | Drug | Warfarin tablet (adjustment by each patients) |
|
| Tokyo, Shinagawa |
| 1416017 |
| Japan |
Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Warfarin | Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Warfarin | Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF. | 0 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |