Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Dabigatran; Drug: Warfarin

• Registration Number: NCT02631057
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-15
• Study Start: 2016-09-01
• Primary Completion: 2016-09-07
• Study Completion: 2016-09-07
• Status Verified: 2017-08
• Results First Submitted: 2017-08-30
• Results First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Results First Posted: 2018-03-30
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4313

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Valvular Atrial Fibrillation	Dabigatran	-
acute ischemic stroke	Warfarin	-

Primary Outcome Measures

Name	Time	Method
Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline	From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.	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.

Trial Locations

Locations (2)

NISED Center; 🇯🇵 Tokyo, Shinagawa, Japan

1160.254.81001 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinagawa, Japan