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临床试验/NCT01621451
NCT01621451Unknown4 期

Does Early Re-administration of Aspirin/Clopidogrel Increase the Risk of Bleeding From Artificial Ulcer After EMR or ESD?

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
400
试验地点
1
主要终点
delayed ulcer bleeding

研究概览

简要总结

Aspirin and/or clopidogrel users are increasing due to increased prevalence of cardiovascular or cerebrovascular disease with an aging society in Korea. Also, the patients having endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for early gastric cancer or gastric premalignant lesions including adenoma and dysplasia are increasing among aspirin and/or clopidogrel users. Practically, aspirin or clopidogrel is recommended to be stopped for 5~14 days before EMR or ESD because bleeding risk during or after procedure. And it is recommended to restart of aspirin and/or clopidogrel as soon as possible if immediate bleeding during or after the procedure is not occurred in consideration of thromboembolic risk. However, early restarting of aspirin and/or clopidogrel raise the risk of delayed bleeding and the risk of complications associated with delayed ulcer healing. Although it is important to determine the timing of restarting aspirin and/or clopidogrel in consideration of complications of post-EMR/ESD ulcer and thromboembolic risk, there is no definite guideline about the timing of restarting aspirin and/or clopidogrel.

This study is aimed to determine the timing of restarting aspirin and/or clopidogrel for the patients having EMR or ESD among aspirin and/or clopidogrel users. The investigators planned to compare the delayed bleeding rate and ulcer healing rate in patients with post-EMR/ESD ulcer when take proton pump inhibitor (pantoprazole 40 mg per day) between the patients restarting aspirin and/or clopidogrel within 3~4 days after the procedure and the patients restarting aspirin and/or clopidogrel 2 weeks after the procedure during 4 weeks. The primary endpoint is delayed ulcer bleeding rate at 4 weeks after EMR/ESD. The secondary end point is ulcer healing rate within 4 weeks.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have taken aspirin and/or clopidogrel for cardiovascular and/or cerebrovascular disease and are found to have early gastric cancer or premalignant lesions including adenoma and dysplasia by upper endoscopy.

排除标准

  • Patients with known coagulopathy or abnormal coagulation tests (prothrombin time, partial thromboplastin time and platelet count)
  • Patients receiving other antithrombotic, anticoagulant drugs
  • Patients needing continuation of nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, or steroid after EMR/ESD
  • Patient with recent percutaneous coronary intervention (placement of drug eluting coronary artery stent within 12 months, bare metal coronary artery stents within 1 month)
  • Patient's age > 80 year-old or < 18 year-old
  • Patient with severe cardiovascular, pulmonary, hepatic, or renal disease

研究组 & 干预措施

immediate

Active Comparator

Patients who receive pantoprazole plus aspirin and/or clopidogrel within 3~4 days after EMR/ESD

干预措施: aspirin and/or clopidogrel (Drug)

2 weeks

Active Comparator

Patients who receive pantoprazole plus aspirin and/or clopidogrel at 2 weeks after EMR/ESD

干预措施: aspirin and/or clopidogrel (Drug)

结局指标

主要结局

delayed ulcer bleeding

时间窗: 4 weeks

次要结局

  • ulcer healing rate(4 weeks)

研究者

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

Hwoon-Yong Jung

Professor

Asan Medical Center

研究点 (1)

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