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| Sponsor: | Taipei Veterans General Hospital,Taiwan |
|---|---|
| Information provided by: | Taipei Veterans General Hospital,Taiwan |
| ClinicalTrials.gov Identifier: | NCT00854776 |
Purpose
Studies showed that combined use of clopidogrel and aspirin had a 25 % reduction of risk on myocardial infarction and stroke in patients who undergone percutaneous coronary intervention (PCI) when compared with use of aspirin alone. However, major GI bleeding rose in combined group than aspirin group. Use of proton pump inhibitor (PPI) which diminishes gastric acid secretion effectively reduces aspirin or clopidogrel associated ulcer or/and ulcer bleeding in general population and high risk patients. The investigator hypothesis is whether use of PPI can reduce ulcer and ulcer complication in patients taking both clopidogrel and aspirin.
| Condition | Intervention |
|---|---|
|
Peptic Ulcer Ulcer Complications |
Drug: lansoprazole Drug: aluminum hydroxide 334 mg and Mg hydroxide 166 mg |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Occurrence of Peptic Ulcer Disease and Its Complications in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without co-Prescription of Proton Pump Inhibitor |
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Upper GI tract symptoms are evaluated. Patients are asked to report to gastroenterologist if they have persistent ulcer symptoms and to report to the emergency room if they have evidence of GI bleeding or ulcer complications (melena, hematemesis, or sudden onset of severe epigastric pain). Endoscopy will be undergone to document any gastroduodenal ulcers with or without ulcer complications. If the hemoglobin level has decreased by 2g/dL or more, or stool check shows occult blood at each visit, endoscopy will be undergone to check the presence of gastroduodenal ulcers with or without bleeding. Patients without persistent ulcer symptoms or without evidence of ulcer complications will be invited to undergone scheduled endoscopy at the 3-month end of follow-up in each subjective.
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Drug: lansoprazole
30 mg once daily
|
|
2: Placebo Comparator
Upper GI tract symptoms are evaluated at each visit. Patients are asked to report to gastroenterologist if they have persistent ulcer symptoms and to report to the emergency room if they have evidence of GI bleeding or ulcer complications (melena, hematemesis, or sudden onset of severe epigastric pain). Endoscopy will be undergone to document any gastroduodenal ulcers with or without ulcer complications. An ulcer is defined as a circumscribed mucosal break at least 3 mm in diameter. If the hemoglobin level has decreased by 2g/dL or more, or stool check shows occult blood at each visit, endoscopy will be undergone to check the presence of gastroduodenal ulcers with or without bleeding. Patients without persistent ulcer symptoms or without evidence of ulcer complications will be invited to undergone scheduled endoscopy at the 3-month end of follow-up in each subjective.
|
Drug: aluminum hydroxide 334 mg and Mg hydroxide 166 mg
1 tablet once daily
|
Patients are eligible if they have received PCI for their stenotic coronary arteries. Patients who had a past history of PUD without complication, who have taken aspirin or clopidogrel before enrolling for their CV disease will be allowed to enroll. Patients are excluded if they have New York Heart Association class IV heart failure, if they had contraindications to antithrombotic or antiplatelet therapy, if they have clinical severe thrombocytopenia (platelet count< 80000/mm3), if they have previous disabling, or hemorrhagic stroke or intracranial hemorrhage, if they have severe and unstable conditions in hepatic, renal, and pulmonary disease, if they have unstable and progressive malignancy, if they have epigastralgia or have a positive occult blood in stool, if they have current or recent peptic ulcer disease and take PPI or histamine receptor-2 antagonist without proving healed ulcer by scopy, if they have received a surgical intervention due to ulcer complication (bleeding, perforation, obstruction) in the past. Patient will be randomly assigned aspirin (100 mg/day) plus clopidogrel (75 mg/day) with PPI (lansoprazole-Takepron@ 30 mg/day) or aspirin (100 mg/day) plus clopidogrel (75 mg/day) with placebo (antacid 1 table/day) for 3 months. Patients will be followed as outpatients, with visit every one month, checking blood hemoglobin as well as stool occult blood for 3 months.Patients are asked to report to gastroenterologist if they have persistent ulcer symptoms (epigastric pain, dyspepsia) and to report to the emergency room if they have evidence of GI bleeding or ulcer complications (melena, hematemesis, or sudden onset of severe epigastric pain). Endoscopy will be undergone to document any gastroduodenal ulcers with or without ulcer complications. Patients without persistent ulcer symptoms or without evidence of ulcer complications will be invited to undergone scheduled endoscopy at the 3-month end of follow-up.The primary end point is the occurrence of clinical upper GI events (symptomatic ulcer and ulcer complications-bleeding, perforation, or obstruction). The secondary end point is occurrence of dyspepsia, asymptomatic gastroduodenal ulcers.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jiing-Chyuan Luo, M.D. | 886-2-28712121 ext 3346 | jcluo@vghtpe.gov.tw |
| Taiwan | |
| Taipei Veterans General Hospital | Recruiting |
| Taipei, Taiwan, 11217 | |
| Contact: Jiing-Chyuan Luo, M.D. 886-2-28712121 ext 3346 jcluo@vghtpe.gov.tw | |
| Principal Investigator: Jiing-Chyuan Luo, M.D. | |
More Information
| Responsible Party: | Taipei Veterans General Hospital ( Luo, Jiing-Chyuan, M.D. (Attending Physician of Section of Gastroenterology) ) |
| Study ID Numbers: | V98C1-051 |
| Study First Received: | March 1, 2009 |
| Last Updated: | March 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00854776 History of Changes |
| Health Authority: | Taiwan: Department of Health |
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aspirin clopidogrel proton pump inhibitor peptic ulcer ulcer complications |
|
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Pathologic Processes Stomach Diseases Proton Pump Inhibitors Aspirin Sensory System Agents Therapeutic Uses |
Anti-Ulcer Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Duodenal Diseases Peptic Ulcer Ulcer Cyclooxygenase Inhibitors Gastrointestinal Agents Adjuvants, Immunologic Enzyme Inhibitors Cardiovascular Agents Intestinal Diseases Pharmacologic Actions Aluminum Hydroxide Digestive System Diseases |