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

Kaohsiung Veterans General Hospital.165 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

165

Conditions

Peptic Ulcer

Interventions

esomeprazoleDRUG

esomeprazole 20 mg qd for 6 months

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Recurrent Peptic Ulcer

Number of participants with recurrent peptic ulcer within 6 months

Time frame: 6 months

Secondary Outcomes

Peptic Ulcer Bleeding

participants with peptic ulcer bleeding within 6 months

Time frame: 6 months

Data from ClinicalTrials.gov

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