The Study of Rosuvastatin for Reduction of Postoperative Paroxysmal Atrial Fibrillation in Patient Undergoing Radiofrequency Catheter Ablation
试验速览
- 阶段
- 4 期
- 入组人数
- 346
- 主要终点
- the AF recurrence rate
研究概览
简要总结
The study will select all recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months. To observe the early relapse of atrial fibrillation and the changes of white blood cell count, hs-C reactive protein (CRP), interleukin (IL)-6 and tumor necrosis factor (TNF)-α, and the changes of safety indicators .
This study assumes that the early atrial fibrillation (AF) recurrence will be decreased in patients with paroxysmal AF if rosuvastatin 20mg/d is received from 7 days before surgery in these patients who plan to undergo radiofrequency catheter ablation for consecutive 3 months.
详细描述
This study is a randomized, open-label, multi-centers, parallel-control study to explore whether rosuvastatin 20mg/d could decrease early AF recurrence in patients with paroxysmal AF after radiofrequency catheter ablation. 346 patients with paroxysmal AF are planned to be enrolled. The patients are randomized to receive oral rosuvastatin 20mg/d or control therapy from 7 days before operation and last for 3 months. The early AF recurrence within 90 days after ablation and the changes of 4 inflammatory markers including white blood cell count, hs-CRP, IL-6 and TNF-α and safety indicators will be observed. The study is aim to evaluate the efficacy and safety of rosuvastatin on decreasing early recurrence in patients with paroxysmal AF and discuss its mechanisms of action.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures;
- •Age from 18 to 75 years old, male or female;
- •The course of paroxysmal AF is more than 3 months and confirmed by ECG;
- •Plan to undergo radiofrequency catheter ablation
排除标准
- •Concomitant with serious organic heart disease such as valvular heart diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardial infarction and unstable angina pectoris;
- •Concomitant with sinoatrial node functional disorder and (or) atrioventricular block;
- •Acute cerebral apoplexy or contraindication of anticoagulant;
- •Thyroid function abnormality;
- •Accepted radiofrequency catheter ablation (RFCA) previously;
- •Being receiving other statins;
- •Be allergic to statins;
- •Pregnancy or women during lactation period;
- •Be not aligning to treatment or follow-up due to mental disorders or other reasons;
- •Be with myopathy or active hepatopathy including agnogenic persistent elevation of serum transaminase and any serum transaminase being over 3 times of upper limit of normal;
- •Be with serious renal dysfunction (creatinine≥3 mg/dL);
- •Need steroid or non-steroid anti-inflammatory drugs to treat inflammation.
研究组 & 干预措施
rosuvastatin 20mg/day
To receive oral rosuvastatin 20mg/day and regular therapy from 7 days before ablation and last for 3 months.
干预措施: rosuvastatin (Drug)
结局指标
主要结局
the AF recurrence rate
时间窗: within 90 days after radiofrequency catheter ablation.
次要结局
- The inflammatory markers (IL-6)(at 24 hours, 72 hours, and 3 months after operation)
- the AF recurrence rate(at 24 hours, 72 hours, 1month, 2 months and 3 months after operation)
- The inflammatory markers (hs-CRP)(at 24 hours, 72 hours, and 3 months after operation)
- The inflammatory markers (white blood cell count)(at 24 hours, 72 hours, and 3 months after operation)
- The inflammatory markers (TNF-α)(at 24 hours, 72 hours, and 3 months after operation)