Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Number of Participants With Healed Peptic Ulcer
研究概览
简要总结
Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.
详细描述
The aim of the prospective, randomized study is investigate the efficacy of H2 receptor antagonist in prevention of thienopyridine-related peptic ulcer and gastrointestinal bleeding in patients with an ulcer history. We plan to enroll 236 thienopyridine (clopidogrel or ticlopidine) users with a peptic ulcer history who don't have baseline gastroduodenal ulcers at initial endoscopy . The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months. The ulcer recurrence rate between the treatment gruops will be compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms.
- •thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy.
- •They are adult patients aged least 20 years of age.
排除标准
- •They have a history of gastric or duodenal surgery other than oversewing of a perforation.
- •They require long-term treatment with non-steroidal anti-inflammatory drugs.
- •serious disease.
研究组 & 干预措施
histamine-2 receptor antagonist group
famotidine 40mg qd for 6 months.
干预措施: histamine-2 receptor antagonist (Drug)
placebo group
placebo for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Healed Peptic Ulcer
时间窗: 6 months
Follow-up endoscopy was performed at the end of the 6th month
次要结局
未报告次要终点
研究者
Ping-I (William) Hsu, M.D.
Professor
Kaohsiung Veterans General Hospital.