Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years, male or female.
- •Diagnosis of persistent atrial fibrillation (AF) scheduled for first catheter ablation.
- •Able to provide written informed consent.
- •Able to comply with study follow-up and ECG monitoring requirements.
排除标准
- •Previous catheter ablation for atrial fibrillation.
- •Life expectancy <12 months due to non-cardiac comorbidities.
- •Severe valvular heart disease requiring surgery or intervention.
- •Acute myocardial infarction or stroke within the past 3 months.
- •Current participation in another investigational drug/device study.
- •Inability to adhere to study procedures or follow-up.
- •Pregnancy or breastfeeding (female participants).
研究组 & 干预措施
Ezetimibe Intervention Arm
Participants in this group will receive 10 mg of oral ezetimibe once daily for six consecutive months starting on the day of catheter ablation. Hobimibe use is strictly prohibited throughout the treatment period. All patients will receive standardized post-ablation clinical management, including anticoagulation therapy, heart rate control, and cardiovascular risk factor modification.
干预措施: Standardized post-ablation clinical management (Other)
Control Arm
Participants in this arm will not receive ezetimibe or hobimibe, but will receive identical standardized post-ablation clinical management (anticoagulation, heart rate control, and risk factor modification) as the Ezetimibe Intervention Arm.
干预措施: Standardized post-ablation clinical management (Other)
Ezetimibe Intervention Arm
Participants in this group will receive 10 mg of oral ezetimibe once daily for six consecutive months starting on the day of catheter ablation. Hobimibe use is strictly prohibited throughout the treatment period. All patients will receive standardized post-ablation clinical management, including anticoagulation therapy, heart rate control, and cardiovascular risk factor modification.
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Recurrence of atrial tachyarrhythmia (≥30 seconds) after blanking period within 6 months post-ablation
时间窗: 6 months post-ablation
次要结局
- Cardioversion rate(6 months post ablation)
- Atrial fibrillation burden at 6 months post-ablation(6 months post-ablation)
- Early recurrence within blanking period:(Within 3 months post-ablation)
- Rehospitalization rate(6 months post-ablation)
- Change in left atrial anteroposterior diameter (LAD) from baseline to month 6(6 months post-ablation)
- Change in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score(6 months post-ablation)
- Composite endpoint comprising cardiovascular death, hospitalization attributable to atrial fibrillation or heart failure, cardioversion, and repeat catheter ablation(6 months post ablation)
- Changes in brain injury-related biomarkers(6 months post-ablation)
- Changes in blood lipid levels from baseline(6 months post-ablation)