NCT01212250招募中不适用
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- the proportions of patients who develop esophageal varices at 1 year in each group.
研究概览
简要总结
Patients of cirrhosis aged 18 to 75 years who have no esophageal varices 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.
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
- Double (Participant, Investigator)
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 aged 18 to 75 years who have no esophageal or gastric varices.
排除标准
- •Any contra-indication to beta-blockers
- •Any past EVL or sclerotherapy
- •Any past history of surgery for portal hypertension
- •Significant cardio or pulmonary co-morbidity
- •Any malignancy
- •Refusal to participate in the study
研究组 & 干预措施
Carvedilol
Experimental
Tablet 6.25 mg BD
干预措施: carvedilol (Drug)
placebo
Placebo Comparator
Placebo tablets 2 BD
干预措施: Placebo (Drug)
结局指标
主要结局
the proportions of patients who develop esophageal varices at 1 year in each group.
时间窗: 1 year
次要结局
- Number of patient dying in a period of one year(1 year)
- Number of patients needing discontinuation of therapy due to adverse effects.(1 year)
- Reduction in Hepatic Venous Pressure Gradient in both groups(1 year)
研究者
研究点 (1)
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