Clinical and Economic Outcomes and Treatment Patterns for Non-Valvular Atrial Fibrillation Patients Who Newly Initiated Oral Anticoagulants in the US Medicare Population

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37513
• EU PAS number:
  EUPAS25230
• Study ID:
  37513
• Official title and acronym:
  Clinical and Economic Outcomes and Treatment Patterns for Non-Valvular Atrial Fibrillation Patients Who Newly Initiated Oral Anticoagulants in the US Medicare Population
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will add “real-world” evidence for the comparative risks of stroke/SE, major bleeding, related health care costs, and treatment patterns among elderly NVAF patients who initiated OACs.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Actual: 29/07/2017

Study start date

Actual: 08/08/2017

Date of final study report

Actual: 31/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

SIMR_Pfizer_Apixaban_Medicare_Protocol_03NOV2017

Regulatory

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