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

NCT00854776 | Unknown DMC

• 1 other identifier: V98C1-051
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer; Ulcer Complications

Keywords

aspirin; clopidogrel; proton pump inhibitor; peptic ulcer; ulcer complications

Outcome Measures

Primary Outcomes (1)

• The primary end point is the occurrence of clinical upper GI events (symptomatic ulcer and ulcer complications-bleeding, perforation, or obstruction)

  3 month follow-up

Secondary Outcomes (1)

• The secondary end point is occurrence of dyspepsia, asymptomatic gastroduodenal ulcers

  3 month follow-up

Study Arms (2)

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.

Drug: lansoprazole

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

Interventions

lansoprazole DRUG

30 mg once daily

Also known as: Takepron

1

aluminum hydroxide 334 mg and Mg hydroxide 166 mg DRUG

1 tablet once daily

2

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Lansoprazole; Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Central Study Contacts

Jiing-Chyuan Luo, M.D.

CONTACT

886-2-28712121; jcluo@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 1, 2009
• First Posted: March 3, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 8, 2010

Record last verified: 2010-06

Locations

TW (1)