UMIN ID: UMIN000001610
Registered date:05/01/2009
Gastrointestinal bleeding complicating antiplatelet treatment after percutaneous coronary intervention(PCI)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | patients for indicated antiplatelet treatment after percutaneous coronary intervention(PCI) |
Date of first enrollment | 2008/09/01 |
Target sample size | 240 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | endoscopic findings is normal and no symptom case: they randomly divided into three treatment arms in each of the groups. Each group was randomly assigned to receive 10 mg omeprazole once a day after breakfast, 100 mg rebamipide 3 times per day after each meal, or no receiving drug during 6 months. patients have endoscopic findings and/or symptom : they randomly divided into two treatment arms in each of the groups. Each group was randomly assigned to receive 10 mg omeprazole once a day after breakfast, 100 mg rebamipide 3 times per day after each meal 6 months. when patients have peptic uler, they received H. pylori eradication therapy. afer that, they receive 10 mg omeprazole once a day after breakfast. |
Outcome(s)
Primary Outcome | The current study attempted to compare the efficacy of rabeprazole with omeprazole in patients indicated for antiplatelet treatment after PCI |
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Secondary Outcome | upper gastrointestinal bleeding. Gastrointestinal symptom(Gastrointesitinal Symptom Rating Scale). |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | Patients were excluded if patients had been malignant disease, previous upper abdominal surgery, neuropsychiatric disorder, organic brain damage, severe hepato-renal disorder, symptoms suggesting or were pregnant. |
Related Information
Primary Sponsor | Graduate School of Medicine Science, Kumamoto University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Graduate School of Medicine Science, Kumamoto University |
Secondary ID(s) |
Contact
public contact | |
Name | Kouichi Sakurai |
Address | 1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN |
Telephone | 096-373-5150(+81-96-373-5150) |
Affiliation | Graduate School of Medicine Science, Kumamoto University Department of Gastroenterology and Hepatology, |
scientific contact | |
Name | Yutaka Sasaki |
Address | 1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN Japan |
Telephone | 096-373-5150 |
Affiliation | Graduate School of Medicine Science, Kumamoto University Department of Gastroenterology and Hepatology, |