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

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631057
• Other study ID #: 1160.254
• Status: Completed
• First received: December 8, 2015
• Last updated: August 30, 2017
• Start date: September 1, 2016
• Est. completion date: September 7, 2016

Study information

• Verified date: August 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4313
• Est. completion date: September 7, 2016
• Est. primary completion date: September 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dabigatran
Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day
• Warfarin
Warfarin tablet (adjustment by each patients)

Locations

Country	Name	City	State
Japan	1160.254.81001 Boehringer Ingelheim Investigational Site	Shinagawa
Japan	NISED Center	Tokyo, Shinagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline	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.

External Links

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