Risk of major bleeding and associated health care resource utilization in non-valvular atrial fibrillation patients who initiated NOACs vs VKAs in the Hungarian population. A stratification on the propensity score method study.

Study identification

• EU PAS number:
  EUPAS30879
• Study ID:
  30880
• Official title and acronym:
  Risk of major bleeding and associated health care resource utilization in non-valvular atrial fibrillation patients who initiated NOACs vs VKAs in the Hungarian population. A stratification on the propensity score method study.
• DARWIN EU® study:
  No
• Study countries:
  Hungary
• Study description:
  The primary objective of the study is to give a descriptive analysis of the utilization of NOACs (apixaban, dabigatran, rivaroxaban) and VKAs (warfarin, acenocoumarol) in patients with NVAF in daily clinical practice on a large administrative database. The secondary objective of the study is to compare major bleeding rates and associated health care resource utilization between each NOAC and VKA users. A population based descriptive and stratification on the propensity score method, retrospective observational study using structured data from National Health Insurance Fund Administration database.
• Study status:
  Planned

Research institutions and networks

Institutions

Medical School Pécs

Study timelines

Date when funding contract was signed

Planned: 05/07/2018

Study start date

Planned: 01/10/2019

Data analysis start date

Planned: 01/11/2019

Date of final study report

Planned: 31/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Hungary

Regulatory

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

Other study registration identification numbers and links

Protocol number: X9001238