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

• ClinicalTrials.gov Identifier: NCT00854776
• Recruitment Status: Unknown
• First Posted: March 3, 2009
• Last Update Posted: June 8, 2010
• Sponsor: Taipei Veterans General Hospital, Taiwan
• Information provided by: Taipei Veterans General Hospital, Taiwan

Tracking Information

• First Submitted Date: March 1, 2009
• First Posted Date: March 3, 2009
• Last Update Posted Date: June 8, 2010
• Study Start Date: January 2009
• Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 2, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 2, 2009): The secondary end point is occurrence of dyspepsia, asymptomatic gastroduodenal ulcers [ Time Frame: 3 month follow-up ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Peptic Ulcer Disease in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Proton Pump Inhibitor
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Peptic Ulcer
• Ulcer Complications

Intervention

• Drug: lansoprazole
  30 mg once daily
  Other Name: Takepron
• Drug: aluminum hydroxide 334 mg and Mg hydroxide 166 mg
  1 tablet once daily

Study Arms

• 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.
  Intervention: Drug: lansoprazole
• 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.
  Intervention: Drug: aluminum hydroxide 334 mg and Mg hydroxide 166 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 2, 2009): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT00854776
• Other Study ID Numbers: V98C1-051
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Luo, Jiing-Chyuan, M.D. (Attending Physician of Section of Gastroenterology), Taipei Veterans General Hospital
• Study Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Taipei Veterans General Hospital, Taiwan
• Verification Date: June 2010