NCT02166008已完成2 期
Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- number of peptic ulcer by end0scopy
研究概览
简要总结
- Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents
- Study Design: Single center, double-blind, randomized-control trial study
- Study drug: Repamipide vs. placebo
- Assessment criteria The patients will be discharged from the study when one of the followings occurred,
- Peptic ulcer from upper endoscopy at 3 and 6 month follow up
- Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy
- Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy
- Evidence of recurrent myocardial infarction from stent thrombosis
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 (Participant, Investigator)
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 18-70 year-old
- •Had cardiovascular disease which needed clopidogrel and aspirin
- •Stable enough for gastroscopy
排除标准
- •Gastroscopy revealed peptic ulcer
- •Had contraindication for gastroscopy
- •Not allowed for gastroscopy by cardiologist
研究组 & 干预措施
Repamipide
Active Comparator
Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred
干预措施: Repamipide (Drug)
placebo
Placebo Comparator
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide.
干预措施: Placebo (Drug)
结局指标
主要结局
number of peptic ulcer by end0scopy
时间窗: 1 year
次要结局
未报告次要终点
研究者
Rapat Pittayanon, MD
Doctor
King Chulalongkorn Memorial Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Prevention of oesophageal, gastric, and duodenal lesions in patients taking anti-thrombotic low-dose aspirin with famotidineGastric ulcerISRCTN96975557Greater Glasgow NHS Board (UK)700
已完成
3 期
Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin-Randomized, Multi-center, single-blinded, parallel-group, comparative studyPeptic UlcerJPRN-UMIN000002901CARE Study Group285
已完成
4 期
Rabeprazole Protection of Aspirin Induced Gastric Damage.Normal SubjectsNCT00220857Temple University30
已完成
4 期
Intravenous Proton Pump Inhibitor for Peptic Ulcer BleedingPeptic Ulcer HemorrhageNCT00731601Lotung Poh-Ai Hospital120
已完成
不适用
Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic UlcerPeptic UlcerNCT02418312Kaohsiung Veterans General Hospital.228