Clinical trial NCT03254134: Comparative Effectiveness and Safety Between Warfarin and Dabigatran
Official title: Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 22490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients with atrial fibrillation contained in the Medical Data Vision (MDVI) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence Rate of Stroke and Systemic Embolism (SE)
timeFrame: 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 outcomes:
measure: Incidence Rate of Major Bleeding
timeFrame: 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.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References: