Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Primary Outcome:
研究概览
简要总结
The aim of the study is to investigate whether intravenous infusion of pantoprazole (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute ulcer bleeding and continue to use aspirin
详细描述
Aspirin is an effective treatment for acute stroke and heart attack. However, aspirin also induces ulcer and provokes acute ulcer bleeding. Thus, aspirin is often withheld in acute ulcer bleeding but this precipitate recurrent stroke or heart attack. We previously showed that intravenous infusion of a potent acid suppressant substantially reduced the incidence of recurrent ulcer bleeding in patients who withheld aspirin. The aim of this study is to investigate whether intravenous infusion of an acid suppressant (Pantoprazole) is effective in preventing recurrent ulcer bleeding with continuous use of aspirin.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received daily anti-platelet therapy for vascular prophylaxis before admission and will continue need to do so
- •Patinets with bleeding peptic ulcers;ulcer actively bleeding or with SRH (Forrest I, IIa and IIb ulcers)
- •Endoscopic haemostasis achieved
排除标准
- •Presence of ulcer complication precluding endoscopic treatment such as gastric outlet obstruction or ulcer perforation mandating surgical intervention.
- •Concomitant use of anticoagulant, NSAIDs or steroid
- •Pending to undergo cardiac interventions that need double anti-platelet agent
- •Pregnancy
- •Terminal illness, or cancer
结局指标
主要结局
Primary Outcome:
Recurrent upper gastrointestinal bleeding within 30 days
次要结局
未报告次要终点