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

Study identification

• EU PAS number:
  EUPAS20047
• Study ID:
  21672
• Official title and acronym:
  Comparative Effectiveness and Safety between Warfarin and Dabigatran Using Real World Claims data of Japanese Non-valvular Atrial Fibrillation Patients
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  A non-interventional study based on existing health insurance claims data to compare the effectiveness (stroke/SE) and safety (major bleeding) in patients with atrial fibrillation and newly treated with dabigatran and warfarin in the real world Japanese setting using a claims database
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:17/08/2017

Actual:17/08/2017

Study start date

Planned:24/08/2017

Actual:24/08/2017

Data analysis start date

Planned:14/10/2017

Actual:10/11/2017

Date of final study report

Planned:29/09/2017

Actual:14/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim

Regulatory

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