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

NCT02631057 | Completed Results

• 1 other identifier: 1160.254
• Study Type: observational
• Target: 4,313
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Non-Valvular Atrial Fibrillation

Drug: Dabigatran

acute ischemic stroke

Drug: Warfarin

Interventions

Dabigatran DRUG

Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day

Non-Valvular Atrial Fibrillation

Warfarin DRUG

Warfarin tablet (adjustment by each patients)

acute ischemic stroke

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Japan

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1160.254.81001 Boehringer Ingelheim Investigational Site

Shinagawa City, Japan

Location

NISED Center

Tokyo, Shinagawa, 1416017, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 15, 2015
• Study Start: September 1, 2016
• Primary Completion: September 7, 2016
• Study Completion: September 7, 2016
• Last Updated: March 30, 2018
• Results First Posted: March 30, 2018

Record last verified: 2017-08

Locations

JP (2)