Gastric Ulcer Clinical Trial
Official title:
Comparison of Ulcer Healing in Patients Taking Rabeprazole Plus Aspirin Versus Rabeprazole Plus Clopidogrel for Acute Peptic Ulcer
Clopidogrel causes significantly less peptic ulcer disease (PUD) and ulcer bleeding than
low-dose aspirin in general population. However, clopidogrel is not safe enough for
gastrointestinal (GI) mucosa in patients who had past history of aspirin-associated ulcer or
ulcer bleeding. Aspirin plus proton pump inhibitor (PPI) is superior to clopidogrel alone in
preventing recurrent ulcer bleeding in these high risk patients.
This study is to compare the ulcer healing rate and ulcer bleeding at 12 weeks in patients
with aspirin-associated PUD when they take PPI (rabeprazole 20 mg/day) to treat their PUD
and simultaneously take aspirin or clopidogrel for their cardiovascular (CV) prevention. Two
hundred patients will be randomly assigned rabeprazole (20 mg/day) plus aspirin (100 mg/day)
or rabeprazole (20 mg/day) plus clopidogrel (75 mg/day) for 12 weeks. The primary end point
is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer
bleeding within 12 weeks.
If rabeprazole plus aspirin in not inferior to rabeprazole plus clopidogrel in the incidence
of ulcer healing and ulcer bleeding in the healing phase,PPI plus aspirin rather than PPI
plus clopidogrel will be recommended during acute ulcer healing in patients who need
antiplatelet therapy for their CV prevention.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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