Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Atrial Fibrillation Clinical Trial

Official title:

Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254134
• Other study ID #: 1160-0288
• Status: Completed
• Start date: October 20, 2017
• Est. completion date: November 3, 2017

Study information

• Verified date: July 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

Description:

This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22490
• Est. completion date: November 3, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged >18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)

• having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016

• having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)

Exclusion Criteria:

• patients having less than 12 months of enrolment prior to the index date

• being dialysis or kidney transplant recipients in baseline period

• having either atrial flutter, valvular atrial fibrillation (AF)

• mechanical valve placement, rheumatic AF

• and/or mitral valve prolapse/regurge/stenosis in baseline period

• having record of deep vein thrombosis or pulmonary embolism < 6 months before AF diagnosis in baseline period

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Warfarin
patients treated with warfarin
• Dabigatran
patients treated with Dabigatran

Locations

Country	Name	City	State
Japan	Nippon Boehringer Ingelheim Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Stroke and Systemic Embolism (SE)	Incidence rate of stroke and systemic embolism (SE).	From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
Secondary	Incidence Rate of Major Bleeding	Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.	From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.

External Links

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