NCT00683111已完成4 期
Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- ulcer complication (bleeding/perforation/obstruction)
研究概览
简要总结
Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.)
排除标准
- •known active peptic ulcer disease or gastrointestinal within 8 wk
- •known iron deficiency anemia with Hb < 10 gm/dl
- •mechanical ventilation
- •active cancer, liver cirrhosis, end-stage renal failure
- •life expectancy < 1 yr
- •known allergic to aspirin, clopidogrel, enoxaparin famotidine or esomeprazole
- •pregnancy, lactation, child-bearing potential in the absence of contraception,
- •co-prescription of NSAID, corticosteroid, or warfarin
- •non-oral feeding or impaired GI absorption e.g. vomiting
- •already on proton pump inhibitor for > 1 day or another clinical trial drug for ulcer disease
研究组 & 干预措施
1
Active Comparator
oral esomeprazole 20 mg daily
干预措施: esomeprazole 20 mg daily (Drug)
2
Active Comparator
oral famotidine 40mg daily
干预措施: famotidine 40 mg daily (Drug)
结局指标
主要结局
ulcer complication (bleeding/perforation/obstruction)
时间窗: up to 12 months
次要结局
- Termination of anti-ischemic drug due to ulcer complications; TIMI severity of GI bleeding; Major adverse cardiac event (composite of death from CV causes, recurrent nonfatal MI, or stroke);(up to 12 months)
研究者
研究点 (1)
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