Adverse ReNal OuTcomEs in patients with NoN-Valvular Atrial fibrillation treated with Rivaroxaban or Vitamin K Antagonists (ANTENNA)

Study identification

• EU PAS number:
  EUPAS33537
• Study ID:
  41352
• Official title and acronym:
  Adverse ReNal OuTcomEs in patients with NoN-Valvular Atrial fibrillation treated with Rivaroxaban or Vitamin K Antagonists (ANTENNA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  By evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly heart beats which is not caused by a heart valve problem) who are treated with Rivaroxaban (non-vitamin K antagonist, brand name Xarelto) or vitamin K antagonists (VKAs). The study planned to enroll about 25,000 male or female patients who were at least 18 years old and were new users of Rivaroxaban or VKAs between 01 January 2014 and 30 September 2019. Researchers are especially interested in whether patients experienced under treatment any worsening in kidney function, the onset of acute kidney diseases or injuries. In addition, risk of worsening in kidney function in patients with or without diabetes or heart failures are of interest to the researchers
• Study status:
  Finalised

Research institutions and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Study timelines

Date when funding contract was signed

Planned:02/02/2020

Actual:02/02/2020

Study start date

Planned:01/05/2020

Actual:01/05/2020

Date of final study report

Planned:30/04/2021

Actual:27/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

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