Clinical trial NCT02631057: Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan
Official title: Comparison of the Length of Stay in Patients Hospitalized and Initiated With Dabigatran or Warfarin for a Concomitant Non-Valvular Atrial Fibrillation in Real-world Japanese Therapeutic Practice (SHORT-J)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-12-15
Enrollment: 4313
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japan

Brief 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:

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:

1. 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.
2. 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.
3. Having a record with a confirmed diagnosis of cancer (ICD-10 code C00-C97 \[malignant neoplasm\]) during the study period.
4. Having a record of dialysis (class J038 artificial kidney) during the study period.
5. Having a record of dabigatran use for a purpose other than prevention of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients.
6. Having a record of dabigatran or warfarin before the hospitalization
7. Having a record of new diagnosis of atrial fibrillation after the initiation of dabigatran or warfarin treatment in the hospitalization period.

Primary outcomes:
measure: Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline
timeFrame: From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Shinagawa
country: Japan
facility: 1160.254.81001 Boehringer Ingelheim Investigational Site
city: Tokyo, Shinagawa
country: Japan
facility: NISED Center
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: