Peptic Ulcer Disease in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Proton Pump Inhibitor
NCT00854776 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2010-06-08
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
Interventions
- DRUG
-
lansoprazole
30 mg once daily
- DRUG
-
aluminum hydroxide 334 mg and Mg hydroxide 166 mg
1 tablet once daily
Sponsors & Collaborators
-
Taipei Veterans General Hospital, Taiwan
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2010-12-31
- Completion
- 2010-12-31
Countries
- Taiwan
Study Locations
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