NCT01037491

Comparison of Ulcer Healing in Patients Taking Rabeprazole With Different Antiplatelets

Comparison of Ulcer Healing in Patients Taking Rabeprazole Plus Aspirin Versus Rabeprazole Plus Clopidogrel for Acute Peptic Ulcer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Ulcer
• Duodenal Ulcer

Interventions

Type	Name	Description
DRUG	rabeprazole plus aspirin versus rabeprazole plus clopidogrel	The primary end point is treatment success (ulcer healing rate). The secondary end point is incidence of ulcer bleeding within 12 weeks.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-12-23
• Last updated: 2010-06-08

Locations

1 site across 1 country: Taiwan