Rationale and design of a prospective, multicenter, cross-sectional study of appropriateness evaluation of the prescription of non-vitamin K antagonist oral anticoagulants for Chinese atrial fibrillation patients (Chi-NOACs-AF trial)

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are alternative to vitamin K antagonists (VKAs) for stroke prevention in patients with atrial fibrillation (AF). Along with their widespread clinical use in China, the off-label use of NOACs is commonly seen in real-world practice, which could result in adverse drug events and poor clinical outcomes. However, guideline adherence and label adherence for NOAC prescriptions have not been well evaluated in a real-world setting in China. METHODS: Between January 2021 and June 2021, a total of 1,750 outpatients or inpatients with AF will be consecutively enrolled at 26 canters in China. Data on patient demographics, clinical characteristics, treatment strategies, and prescribing information related to anticoagulation therapy for patients with AF will be collected. Clinical pharmacists will evaluate the rationality of the anticoagulation regimens and NOAC prescriptions based on the guideline recommendations and drug labels that are approved by the National Medical Products Administration. The primary outcomes will be the prevalence of irrational anticoagulation strategies and the inappropriate NOAC prescriptions, as well as potential risk factors associated with inappropriate prescriptions in patients with AF. DISCUSSION: This study will be the first national, multicenter, prospective study performed by pharmacists to explore real-world data on the appropriateness of NOAC prescription in Chinese patients with AF. TRIAL REGISTRATION: The Chi-NOACs-AF trial (Trial number: ChiCTR2000035908).