Hospital Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated with Oral Anticoagulants in the U.S.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37527
• EU PAS number:
  EUPAS25238
• Study ID:
  37527
• Official title and acronym:
  Hospital Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated with Oral Anticoagulants in the U.S.
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study will address the following primary research question: What is the frequency of readmission for major bleeding (MB) within 1 month after an index hospitalization for NVAF patients treated with apixaban, dabigatran, rivaroxaban, or warfarin?
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Actual: 09/03/2018

Study start date

Actual: 01/08/2018

Date of final study report

Actual: 27/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

PremierDB_Hospital_OAC_AF_Readmission_Protocol_v9

Regulatory

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