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

NCT ID: NCT02631057

Last Updated: 2018-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4313 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2016-09-07

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-Valvular Atrial Fibrillation

Dabigatran

Intervention Type DRUG

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

acute ischemic stroke

Warfarin

Intervention Type DRUG

Warfarin tablet (adjustment by each patients)

Interventions

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Dabigatran

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

Intervention Type DRUG

Warfarin

Warfarin tablet (adjustment by each patients)

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.254.81001 Boehringer Ingelheim Investigational Site

Shinagawa City, , Japan

Site Status

NISED Center

Tokyo, Shinagawa, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1160.254

Identifier Type: -

Identifier Source: org_study_id

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