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

Study identification

• 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

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:24/11/2016

Actual:24/11/2016

Study start date

Planned:24/11/2016

Data analysis start date

Planned:29/11/2016

Date of final study report

Planned:22/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippong Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable