RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47671
• EU PAS number:
  EUPAS36634
• Study ID:
  47671
• Official title and acronym:
  RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institution and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Planned: 02/07/2020

Actual: 02/07/2020

Study start date

Planned: 21/08/2020

Actual: 21/08/2020

Data analysis start date

Planned: 31/07/2021

Actual: 31/07/2021

Date of final study report

Planned: 31/10/2021

Actual: 05/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

21449_Study Protocol_V1.0_2020-08-19_Redacted

Updated protocol

21449_Study Protocol_V2.0_2020-11-09_Redacted

Regulatory

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