Study identification

PURI

https://redirect.ema.europa.eu/resource/41352

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 institution and networks

Institutions

Contact details

Bayer Clinical Trials BAYER AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Study protocol
Initial protocol

Study 21347_Study protocol_Version 1_02Feb2020

English (1.51 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable