NCT00713947撤回4 期
Comparative Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control on the Gastric Lesions Induced by the Aspirin With the Low Dose Among Patients Treated With the Long Course
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measure: severity of the ulcerated gastric lesions induced by the aspirin
研究概览
简要总结
Low dose of aspirin is the main cause of gastro-duodenal ulcer. The best prevention is not definite particularly in patients without history of ulcer and infected by H. pylori.The aim of the study is to evaluate the gastric damage induced by aspirin in patients with H. pylori infection but who have any history of ulcer.
详细描述
The aim of the study is to compare the protective effect of H. pylori eradication versus Pantoprazole versus placebo on the gastric damage induced by low dose of aspirin. Treatment are attributed by randomisation. Patients are followed for 6 months and gastric damage are evaluated by endoscopy at the end of this period.
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
- Single (Participant)
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 of more than 18 years old
- •Coronarography or coronary imaging or supra-aortic arterial trunks ultrasound examination performed since less 7 months and having at least an arterial vascular stenosis
- •Indication for aspirin treatment for at least 12 months (at the moment of the visit of inclusion) at a posology from 80 to 125 mg per day. The treatment must be prescribed since less than 7 months.
- •Patient who had since less 7 month a positive Helicobacter Pylori serology.
- •For the women in age to procreate, effective mode of contraception (oral contraception, surgical sterilization, coil)
- •Patient having given an informed consent according to recommendation of the CPP (institutional ethical committee).
排除标准
- •treatment by anti-coagulant, whatever its nature and its posology, by proton pump inhibitor, H2 receptor antagonists or antiacid having to be continued beyond the day of inclusion
- •Treatment by methotrexate in progress or stopped since less 3 months.
- •Time of more 7 months enters the beginning of the treatment by aspirin and the visit of inclusion
- •Treatment by NSAID (even occasional or self medication) under or stopped since less 3 months.
- •Treatment by anti-platelet drug (clopidogrel, ticlopidine, flurbiprofen, dipyridamole or antagonist of receptor GPIIb/IIIa) in progress or stopped since less than 10 days.
- •Patient with a serious pathology compromising survival in the 6 month to come.
- •Patient with renal or respiratory insufficiency or a hepatic pathology having a clinical repercussion.
- •History of surgery of esophagus, stomach or duodenum.
- •History of digestive tract bleeding or gastro-duodenal ulcer or esophagal ulcerating proven by endoscopy.
- •Allergy known to clarithromycin.
- •Psychiatric disorder not controlled by treatment.
- •Patients all ready include in a therapeutic protocol or to be followed for 6 month.
- •Alcohol consumption higher than 100gr. per day.
- •Patient non suitable for participating in the protocol or to be followed for 6 month.
- •History of intolerance to salicylate.
- •Constitutional or acquired hemorrhagic disease
- •Pregnant woman or nursing.
- •Patient in emergency, people hospitalized without their assent, people without freedom, people without social health insurance.
研究组 & 干预措施
A
Active Comparator
Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo
干预措施: during one week for the active treatments (Drug)
B
Experimental
Pantoprazole
干预措施: Pantoprazole (Drug)
C
Placebo Comparator
Placebo
干预措施: Placebo Formula 515 (Drug)
结局指标
主要结局
Measure: severity of the ulcerated gastric lesions induced by the aspirin
时间窗: 6 months
次要结局
- To measure : Elements of the histopathologic score of Sydney(6 months)
- To measure percentage of patients having had digestive clinical events(6 months)
- To measure: percentage of patients having had at least an ulcer(6 months)
- To measure: the average of the ranks of severity of the hemorrhagic lesions and erosive lesions evaluated in antrum and corpus by two analogical scales of 150 mm(6 months)
- To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.(6 months)
- To measure: the average of the ranks of lesion in antrum and corpus.(6 months)
研究者
研究点 (1)
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