The Effect of Carvedilol Vs Propranolol in Patients With Cirrhosis Related Esophagogastric Varices After Multiple Endoscopic Treatments For Secondary Prophylaxis:A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Endoscopic Retreatment
研究概览
简要总结
To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.
详细描述
The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the Propranolol group. Treatment allocation is by block randomization, with an equal number for Carvedilol and Propranolol. The results are concealed in opaque envelopes. The dose of non-selective β-blocker(NSBB) is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Patients receiving propranolol start at a dose of 30 mg/day and the dose will be increased to a maximum dose of 160 mg/day. Patients will be followed up with telephone calls every 2 months. After taking these 2 drugs for 6 months, patients come for clinic visits, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18-70 years old;
- •cirrhotic patients referred to Zhongshan Hospital with esophagogastric varices confirmed by endoscopy;
- •history of variceal bleeding; at least 3 times of endoscopic treatment;
- •with 1) mild esophageal varices;2) gastric varices with a diameter less than 5mm; or 3) variceal eradication at the time of recruiting.
排除标准
- •Patients are excluded when they have
- •episodes of variceal bleeding after the last endoscopic treatment;
- •diagnosis of hepatic cellular carcinoma;
- •severe systemic diseases;
- •refractory ascites;
- •contraindication to Carvedilol or Propranolol, such as: asthma, chronic obstructive pulmonary disease, allergic rhinitis, New York Heart Association IV chronic heart failure, atrioventricular blockade, severe bradycardia(HR<50bpm), sick sinus syndrome, cardiogenic shock, severe hypotension(ABPsys<85mmHg);
- •previous and continued use of β-blockers;
- •Child -Pugh Class C.
研究组 & 干预措施
Carvedilol
Carvedilol，6.25mg-25mg/d,oral,6 months
干预措施: Carvedilol (Drug)
Propranolol
Propranolol,30mg-160mg/d,oral,6 months
干预措施: Propranolol (Drug)
结局指标
主要结局
Endoscopic Retreatment
时间窗: 6 months
Patients will receive an endoscopic examination after they have been followed up for 6 months, and if they have recurrence of varices or deterioration of varices,they are considered to be in need of endoscopic retreatment.
次要结局
- Adverse events(6 months)
- Rebleeding rate(6 months)
- Mortality rate(6 months)
研究者
Shiyao Chen
Director of department of Gastroenterology, Zhongshan Hospital
Shanghai Zhongshan Hospital