Clinical trial NCT02982863: Treatment Pattern of Oral Anticoagulants (OAC) in Japan
Official title: Treatment Patterns of Newly Initiated Oral Anticoagulants on Japanese Non-valvular Atrial Fibrillation Patients Using a Japanese Claims Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-12-06
Enrollment: 48696
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: Medical Data Vision (MDV) clinical database

Brief summary: 1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
2. To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database


Eligibility criteria: Inclusion criteria:

* Patients aged \>18 year-old with confirmed diagnosis of NVAF (ICD 10 code I48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other OACs for12 months prior to the index date (defined as the first prescription of OACs (the period is defined as baseline period)), and having an index date between 14 Mar 2011 to 30 June 2016

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 AF, mechanical valve placement, rheumatic AF, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism \< 6 months before Atrial Fibrillation (AF) diagnosis in baseline period

Primary outcomes:
measure: Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF
timeFrame: Day 1
measure: Number of Patients Prescribed OAC Drug Dabigatran by Dosage
timeFrame: Day 1
measure: Number of Patients Prescribed OAC Drug Warfarin by Dosage
timeFrame: Day 1
measure: Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
timeFrame: Day 1
measure: Number of Patients Prescribed OAC Drug Apixaban by Dosage
timeFrame: Day 1
measure: Number of Patients Prescribed OAC Drug Edoxaban by Dosage
timeFrame: Day 1
Secondary outcomes:
measure: Baseline Characteristics: Age
timeFrame: 1 day
measure: Baseline Characteristics: Gender
timeFrame: Day 1
measure: Baseline Characteristics: Year of Initiating Treatment
timeFrame: Day 1
measure: Baseline Characteristics: Speciality of Prescribers of OAC
timeFrame: Day 1
measure: Baseline Characteristics: History of Disease
timeFrame: Day 1
measure: Baseline Characteristics: History of Hospitalization
timeFrame: Day 1
measure: Baseline Characteristics: AF Risk Score
timeFrame: Day 1
measure: Baseline Characteristics: Concomitant Medication
timeFrame: Day 1
Other outcomes:
Locations:
city: Tokyo, Shinagawa
country: Japan
facility: NISED Center
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: