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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Esomeprazole plus clopidogrel group

esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months

Group Type ACTIVE_COMPARATOR

esomeprazole

Intervention Type DRUG

esomeprazole 20 mg qd for 6 months

Clopidogrel group

clopidogrel 75 mg qd for 6 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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esomeprazole

esomeprazole 20 mg qd for 6 months

Intervention Type DRUG

Other Intervention Names

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plavix

Eligibility Criteria

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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.