Rivaroxaban real world effectiveness in patients with atrial fibrillation (GUARDIAN)

Study identification

• EU PAS number:
  EUPAS1000000869
• Study ID:
  1000000869
• Official title and acronym:
  Rivaroxaban real world effectiveness in patients with atrial fibrillation (GUARDIAN)
• DARWIN EU® study:
  No
• Study countries:
  Bosnia and Herzegovina

  Serbia
• Study description:
  Atrial fibrillation is the most common sustained cardiac arrhythmia in adults and is associated with substantial morbidity and mortality, portending significant burden to patients, societal health and health economy. The currently estimated prevalence of AF in adults is between 2 % and 4 %, and a 2,3-fold rise is expected, owing to extended longevity in the general population and intensifying search for undiagnosed atrial fibrillation (AF). When AF is undetected or untreated, it can lead to serious complications, the most important is creation of blood clots that can lead to stroke. Overall AF increases the risk of stroke five-fold. Oral anticoagulants (OAC) represent the cornerstone therapy in stroke prevention. Rivaroxaban is one of four Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) that have been approved for the reduction of stroke risk and systemic embolism in patients with AF and first in the class that directly inhibits both free and clot-bound Factor Xa and prevents the formation of new clots and the extension of existing clots. Non-interventional study with Krka’s rivaroxaban evaluates its real-world effectiveness in heterogeneous population with atrial fibrillation and variety of risk factors. The study provides the therapeutic data, reflecting actual clinical aspects in the field of treatment with rivaroxaban and its role and value in improving patients’ outcomes in treatment of AF.
• Study status:
  Finalised

Research institutions and networks

Institutions

University Clinical Center of Serbia (UCCS)

Serbia

Zenica Cantonal Hospital

Study timelines

Date when funding contract was signed

Planned:01/05/2022

Actual:25/05/2022

Study start date

Planned:01/09/2022

Actual:01/09/2022

Data analysis start date

Planned:01/01/2025

Actual:27/01/2025

Date of final study report

Planned:01/07/2025

Actual:21/11/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Representative offices or companies of Krka d.d., Novo mesto who participated in the study.

Regulatory

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