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临床试验/NCT01447498
NCT01447498已完成不适用

Effect of a Systematic Screening for Risk-factors for Ulcer Bleeding Before Post-PCI Anti-thrombotic Treatment

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 2,024 人开始时间: 2011年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,024
试验地点
2
主要终点
Admission for ulcer bleeding or haemorrhagic gastritis

研究概览

简要总结

In a prospective randomised study design to investigate, if a systematic risk factor screening for bleeding ulcer in patients, who following percutaneous coronary intervention (PCI) commence a one year combination treatment with low dose aspirin and clopidogrel, followed by prophylactic treatment with a proton pump inhibitor (PPI) in case of increased risk, can reduce the risk of bleeding ulcer. Based on the recently raised suspicion that PPI's, possibly except pantoprazole, reduce the effect of ADP-receptor inhibitors, pantoprazole has been chosen as prophylaxis in the screening group, and analyses will be done to ascertain whether PPI treatment increases the risk of coronary events. Further analyses will be made to see whether PPI prophylaxis in high risk patients can increase compliance with the antithrombotic treatment through a reduction of side effects, thereby reducing the risk of myocardial infarction in particular stent thrombosis. The study population will be analyzed further to identify the patients, who will benefit the most from PPI prophylaxis Hypothesis: screening heart patients for risk factors for bleeding ulcer and subsequently treating high risk patients with PPI can reduce the incidence of bleeding ulcer and increase compliance with the antithrombotic treatment; thereby possibly reducing the risk of coronary events and improving survival. Initial a description of the prevalence of risk factors will be done.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who has had a PCI with stenting or balloon dilatation in the cardiology department at Odense University Hospital, Århus University Hospital and Ålborg Sygehus, where subsequent treatment with low-dose aspiring and clopidogrel or another thienopyridine is planned for one year.

排除标准

  • previous PCI with stenting or balloon dilatation
  • treatment with clopidogrel prior to PCI
  • lack of informed consent

研究组 & 干预措施

Control group

No Intervention

Screening and risk assessment

Active Comparator

干预措施: Screening for risk factors for ulcer bleeding (Other)

结局指标

主要结局

Admission for ulcer bleeding or haemorrhagic gastritis

时间窗: 1 year

Efficacy of a systematic screening for risk factors for ulcer bleeding in patients, who after percutaneous coronary intervention (PCI), is treated with antithrombotic medicine

次要结局

  • Compliance with antithrombotic medicine(1 year)
  • Identification of patients with benefit of proton pump inhibitor prophylaxis(1 year)
  • Gastrointestinal bleeding(1 Year)
  • Uncomplicated ulcers(1 year)
  • Death(1 Year)
  • Acute coronary syndrome(1 Year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berit Elin Søltoft Jensen

MD sub-investigator

Odense University Hospital

研究点 (2)

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