ezetimibe
DrugOral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
NCT Number: NCT07752758
This single-center, prospective, single-blind randomized controlled pilot trial aims to explore whether oral ezetimibe can reduce the 6-month recurrence rate of atrial tachyarrhythmia after catheter ablation in patients with persistent atrial fibrillation. A total of 120 eligible patients will be randomized at a 1:1 ratio into the ezetimibe group and the control group within 24 hours after ablation. Stratified randomization based on body mass index (BMI) and left atrial diameter will be performed via an interactive web response system (IWRS). This study adopts a single-blind design: patients and investigators are unblinded to group allocation, whereas an independent Endpoint Adjudication Committee consisting of three electrophysiologists will blindly review all ECG data to determine arrhythmia recurrence. The intervention group will receive 10 mg oral ezetimibe once daily for six months following ablation, and the use of hobimibe is prohibited in this group. The control group will refrain from the use of both ezetimibe and hobimibe, with standardized postoperative management maintained consistently across the two groups. The primary endpoint is the recurrence of atrial tachyarrhythmia lasting ≥30 seconds after the blanking period within six months post-ablation. Secondary endpoints include early atrial tachyarrhythmia recurrence, atrial fibrillation burden, changes in left atrial diameter, quality of life scores, and composite cardiovascular events. Safety outcomes encompass hepatic and muscular adverse reactions as well as serious adverse events. This prospective pilot study will provide preliminary clinical evidence for optimizing rhythm control strategies after atrial fibrillation catheter ablation.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral ezetimibe 10 mg once daily, administered for 6 consecutive months starting on the day of catheter ablation.
Anticoagulation therapy, heart rate control, and cardiovascular risk factor modification
Time frame: 6 months post-ablation
Time frame: Within 3 months post-ablation
Recurrence of atrial tachyarrhythmia lasting ≥30 seconds within 3 months
Time frame: 6 months post-ablation
Time frame: 6 months post ablation
Time frame: 6 months post-ablation
Time frame: 6 months post-ablation
Time frame: 6 months post-ablation
Time frame: 6 months post ablation
Time frame: 6 months post-ablation
Serum neurofilament light chain (sNfL, pg/mL), Serum phosphorylated tau 217 (p-Tau217, pg/mL)
Time frame: 6 months post-ablation
Low-density lipoprotein cholesterol (LDL-C, mmol/L), Triglycerides (TG, mmol/L)
Second Affiliated Hospital, Zhejiang University, School of Medicine
Other
Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study
Acronym: EAFA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07697469
Arrhythmias, Cardiac, Atrial Cardiomyopathy
Iași, Iaşi, Romania
View Trial DetailsNCT05635864
Arrhythmias, Cardiac, Atrial Fibrillation
Hanover, Lower Saxony, Germany
View Trial DetailsNCT07511166
Arrhythmias, Cardiac, Atrial Fibrillation
View Trial DetailsNCT07625215
Arrhythmias, Cardiac, Atrial Fibrillation
San Francisco, California, United States
View Trial Details