Peptic Ulcer Disease in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Proton Pump Inhibitor

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ClinicalTrials.gov Identifier: NCT00854776

Recruitment Status : Unknown

Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was: Recruiting

First Posted : March 3, 2009

Last Update Posted : June 8, 2010

Sponsor:

Information provided by:

Taipei Veterans General Hospital, Taiwan

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Peptic Ulcer Ulcer Complications	Drug: lansoprazole Drug: aluminum hydroxide 334 mg and Mg hydroxide 166 mg	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Study Start Date :	January 2009
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Aluminum Lansoprazole Dexlansoprazole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 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.	Drug: lansoprazole 30 mg once daily Other Name: Takepron
Placebo Comparator: 2 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

Arm

Intervention/treatment

Active Comparator: 1

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.

Drug: lansoprazole

30 mg once daily

Other Name: Takepron

Placebo Comparator: 2

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

Outcome Measures

Primary Outcome Measures :

The primary end point is the occurrence of clinical upper GI events (symptomatic ulcer and ulcer complications-bleeding, perforation, or obstruction) [ Time Frame: 3 month follow-up ]

Secondary Outcome Measures :

The secondary end point is occurrence of dyspepsia, asymptomatic gastroduodenal ulcers [ Time Frame: 3 month follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients are eligible if they have received PCI for their stenotic coronary arteries and taken both aspirin and clopidogrel.
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.

Exclusion Criteria:

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 PUD and take PPI or histamine receptor-2 antagonist without proving healed ulcer by scopy, if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past, if they have received a GP IIb/IIIa inhibitor fewer than 3 days before randomization.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854776

Contacts

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Contact: Jiing-Chyuan Luo, M.D.	886-2-28712121 ext 3346	jcluo@vghtpe.gov.tw

Locations

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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.

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

More Information

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Responsible Party:	Luo, Jiing-Chyuan, M.D. (Attending Physician of Section of Gastroenterology), Taipei Veterans General Hospital
ClinicalTrials.gov Identifier:	NCT00854776
Other Study ID Numbers:	V98C1-051
First Posted:	March 3, 2009 Key Record Dates
Last Update Posted:	June 8, 2010
Last Verified:	June 2010

Keywords provided by Taipei Veterans General Hospital, Taiwan:


aspirin clopidogrel proton pump inhibitor peptic ulcer ulcer complications

Additional relevant MeSH terms:

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Peptic Ulcer Ulcer Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Lansoprazole Dexlansoprazole	Aluminum Hydroxide Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antacids

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