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

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ClinicalTrials.gov Identifier: NCT02631057
Recruitment Status : Completed
First Posted : December 15, 2015
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Dabigatran Drug: Warfarin

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Study Type : Observational
Actual Enrollment : 4313 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : September 7, 2016
Actual Study Completion Date : September 7, 2016


Group/Cohort Intervention/treatment
Non-Valvular Atrial Fibrillation Drug: Dabigatran
Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day

acute ischemic stroke Drug: Warfarin
Warfarin tablet (adjustment by each patients)




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japan
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631057


Locations
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Japan
1160.254.81001 Boehringer Ingelheim Investigational Site
Shinagawa, Japan
NISED Center
Tokyo, Shinagawa, Japan, 1416017
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02631057     History of Changes
Other Study ID Numbers: 1160.254
First Posted: December 15, 2015    Key Record Dates
Results First Posted: March 30, 2018
Last Update Posted: March 30, 2018
Last Verified: August 2017
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action