A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Early Primary Prophylaxis of Esophageal Varices in Cirrhosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group.
研究概览
简要总结
Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score& adverse events.
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
- Single (Participant)
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
- •Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously.
排除标准
- •Any contra-indication to beta-blockers
- •Any EVL or sclerotherapy within last 3 months
- •Child Turcotte Pugh (CTP) score > 12, refractory ascites, hepatorenal syndrome
- •Any past history of surgery for portal hypertension
- •Significant cardio or pulmonary co-morbidity
- •Any malignancy that affects survival.
- •Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis.
- •Past history of surgery for portal hypertension
- •Uncontrolled diabetes
- •Peripheral vascular disease
- •Refusal to participate in the study
研究组 & 干预措施
Carvedilol
Tablet Carvedilol 12.5 mg BD or maximum tolerated dose
干预措施: Carvedilol (Drug)
Placebo
Placebo tablets 2 to 4 BD
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group.
时间窗: 2 Years
次要结局
- reduction in HVPG(1 Year)
- Survival(2 Years)
- adverse effects of drugs(2 Years)