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

August 30, 2017 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4313

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Shinagawa, Japan
        • 1160.254.81001 Boehringer Ingelheim Investigational Site
      • Tokyo, Shinagawa, Japan, 1416017
        • NISED Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Japan

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acute ischemic stroke
Drug: Warfarin
Warfarin tablet (adjustment by each patients)
Non-Valvular Atrial Fibrillation
Drug: Dabigatran
Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 7, 2016

Study Completion (Actual)

September 7, 2016

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.254

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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