N/A
N=4,313
Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02631057 ↗Enrolled (actual)
4,313
Serious AEs
—
Results posted
Mar 2018
Primary outcome: Primary: Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline — 9.8; 14.9 Months — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dabigatran (Drug); Warfarin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline |
9.8; 14.9 | <0.001 sig |
Summary
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.
Eligibility Criteria
Inclusion criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT02631057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.