A Phase 4 interventional study of aspirin and/or clopidogrel and aspirin and/or clopidogrel in Early Gastric Cancer and Gastric Dysplasia, sponsored by Asan Medical Center. Status unknown at 1 site in South Korea. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-11-22.
Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment
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.
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This study's planned enrollment of 400 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
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Exclusion Criteria:
Patients who receive pantoprazole plus aspirin and/or clopidogrel within 3\~4 days after EMR/ESD
Drug: aspirin and/or clopidogrel
Patients who receive pantoprazole plus aspirin and/or clopidogrel at 2 weeks after EMR/ESD
Drug: aspirin and/or clopidogrel
Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In immediate group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.
Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In 2 weeks group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.
delayed ulcer bleeding
Time frame: 4 weeks
ulcer healing rate
Time frame: 4 weeks
The record gives a start of Jun 2012, a primary completion of May 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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