The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9772
• EU PAS number:
  EUPAS9771
• Study ID:
  9772
• Official title and acronym:
  The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation (NVAF) Patient Population-A Retrospective Database Analysis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is of a retrospective cohort design with propensity score matching. The primary study objective is to assess the safety and effectiveness of dabigatran compared to warfarin in patients diagnosed with non-valvular atrial fibrillation in the DoD population.
• Study status:
  Ongoing

Research institution and networks

Institutions

Evidera

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 27/09/2013

Actual: 27/09/2013

Study start date

Planned: 22/01/2014

Actual: 22/01/2014

Data analysis start date

Planned: 04/07/2014

Actual: 23/05/2014

Date of final study report

Planned: 15/06/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Pharmaceuticals, Inc.

Regulatory

• Was the study required by a regulatory body?:
  No