Study identification

PURI

https://redirect.ema.europa.eu/resource/16393

EU PAS number

EUPAS16392

Study ID

16393

Official title and acronym

Treatment Patterns of newly initiated oral anticoagulants on Japanese non-vascular atrial fibrillation patients using a Japanese claims database

DARWIN EU® study

No

Study countries

Japan

Study description

A retrospective, observational study using health insurance claims data to describe the prescription pattern of oral anticoagulants in Japanese patients with atrial fibrillation. The primary outcome is the type and dose of oral anti-coagulant (warfarin, apixaban, rivaroxaban, dabigatran and edoxaban). The secondary outcome is the patient baseline characteristics of Japanese NVAF patients in each oral anticoagulant cohort. The datasource is Medical Data Vision's claims data containing approximatley 480,000 Japanese patinent data with diagnostic claim of atrial fibrillation. The study includes new starters of anti-coagulants wihtout prior treatment of oral anticoagulant with AF. PS matching between warfarin and dabigatran exposed groups will be conducted based on baseline characteristics and concurrent drug treatment as co-variates.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Yasuhisa Ono

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Nippong Boehringer Ingelheim
Study protocol
Initial protocol

non-interventional-study-protocol-oacs-PDFfinal

English (148.16 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable