The Comparative Safety and Effectiveness of dabigatran, versus rivaroxaban, and apixaban Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation Patient Population-A Retrospective Database Analysis

Study identification

• EU PAS number:
  EUPAS16528
• Study ID:
  24713
• Official title and acronym:
  The Comparative Safety and Effectiveness of dabigatran, versus rivaroxaban, and apixaban Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation Patient Population-A Retrospective Database Analysis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users
• Study status:
  Finalised

Research institutions and networks

Institutions

Late Stage Research, inVentiv Health Clinical

United Kingdom

Study timelines

Date when funding contract was signed

Planned:12/10/2016

Actual:12/10/2016

Study start date

Planned:19/10/2016

Actual:19/10/2016

Data analysis start date

Planned:27/01/2017

Actual:30/01/2017

Date of final study report

Planned:29/06/2018

Actual:04/06/2018

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
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable