Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Phase 2

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: esomeprazole

• Registration Number: NCT01138969
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.

Detailed Description

The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2012-12-31
• Results First Submitted QC: 2012-12-31
• Results First Posted: 2013-02-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-06
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria

• 1.serious disease 2.refuse informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole plus clopidogrel group	esomeprazole	esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months

Primary Outcome Measures

Name	Time	Method
Recurrent Peptic Ulcer	6 months	Number of participants with recurrent peptic ulcer within 6 months

Secondary Outcome Measures

Name	Time	Method
Peptic Ulcer Bleeding	6 months	participants with peptic ulcer bleeding within 6 months

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan