A retrospective cohort study with chart review to assess the management of major bleeding events in NVAF patients treated with dabigatran etexilate

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9981
• EU PAS number:
  EUPAS6568
• Study ID:
  9981
• Official title and acronym:
  A retrospective cohort study with chart review to assess the management of major bleeding events in NVAF patients treated with dabigatran etexilate
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This will be an observational chart review study. Details of major bleeding events will be abstracted from medical records using a standardized data collection tool (electronic case report form (eCRF)).
• Study status:
  Planned

Research institutions and networks

Institutions

inVentive Health

Brigham and Women's Hospital

State University of New York Stony Brook, NY, Maimonides Medical Center New York, Brigham and Women's Hospital Boston, Seton Health Center Texas, Beth Israel Deaconess Medical Center Boston

Study timelines

Date when funding contract was signed

Actual: 09/04/2014

Study start date

Planned: 30/05/2014

Date of final study report

Planned: 20/03/2015

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