NCT02175186已完成4 期
Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Young-Hak Kim, MD, PhD1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2015年1月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Incidence of gastric ulcer
研究概览
简要总结
The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years
- •Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks
- •Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy
- •mild gastrointestinal symptom
- •Creatinen in blood ≤ 3mg/dl
- •BUN ≤ 50mg/dl
- •Birilubin ≤ 3mg/dl
- •AST and ALT ≤ 80U/L
排除标准
- •Pregnant or breast feeding
- •History of Stomach or esophagus surgery
- •Peptic ulcer or reflux esophagitis
- •Zollinger-Ellison syndrome or primary esophageal motility disorders
- •Malignant tumor
- •Bleeding tendency or coagulopathy
- •Contraindication of ALBIS
- •Long term use of aspirin or P2Y12 receptor antagonist within 1month
- •Patients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed)
- •Terminal patient
研究组 & 干预措施
Placebo
Placebo Comparator
placebo Tab 2 tab twice a day 12weeks
干预措施: Placebo (Drug)
ALBIS
Experimental
Albis Tab 2 tab twice a day 12weeks
干预措施: ALBIS (Drug)
结局指标
主要结局
Incidence of gastric ulcer
时间窗: 12weeks
defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks
次要结局
- The Endoscopic improvement rate of hemorrhage(12weeks)
- The Endoscopic improvement rate of subjective symptom(12weeks)
- Total amount of antacid used during study period(12weeks)
- Incidence of gastritis(12weeks)
研究者
Young-Hak Kim, MD, PhD
MD,PhD
Asan Medical Center
研究点 (1)
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