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)

Study identification

• EU PAS number:
  EUPAS13462
• Study ID:
  18496
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective of this study is to compare the LoS from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequentlytreated 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:25/07/2016

Actual:25/07/2016

Study start date

Planned:01/08/2016

Actual:02/09/2016

Data analysis start date

Planned:13/06/2016

Actual:02/09/2016

Date of final study report

Planned:30/09/2016

Actual:14/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co.,Ltd..

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable