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

Kaohsiung Veterans General Hospital

Status and phase: Completed; Phase 2

Conditions: Peptic Ulcer

Treatments: Drug: esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01138969

VGHKS98-CT6-12

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Esomeprazole plus clopidogrel group

Active Comparator group

Description:

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

Treatment:

Drug: esomeprazole

Clopidogrel group

No Intervention group

Description:

clopidogrel 75 mg qd for 6 months