Predictors of Treatment and the Comparative Clinical and Economic Outcomes among Non-Valvular Atrial Fibrillation Patients Treated versus Untreated with Oral
Anticoagulant Therapy (NVAF Diagnosed Untreated)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43073
• EU PAS number:
  EUPAS30448
• Study ID:
  43073
• Official title and acronym:
  Predictors of Treatment and the Comparative Clinical and Economic Outcomes among Non-Valvular Atrial Fibrillation Patients Treated versus Untreated with Oral Anticoagulant Therapy (NVAF Diagnosed Untreated)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will estimate prevalence of newly diagnosed but untreated NVAF patients, add real-world evidence for the predictors of treatment among newly diagnosed NVAF patients. In addition, it will evaluate the risks of major bleeding, stroke/SE, and death by comparing OAC treatment versus no OAC treatment. The comparative health care costs and utilization will also be evaluated.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 14/08/2018

Study start date

Planned: 26/06/2019

Actual: 26/06/2019

Date of final study report

Planned: 30/09/2021

Actual: 11/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

SIMR_Pfizer_Untreated_Medicare_Protocol_13JUN2019_clean (004)

Regulatory

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