Phase 2 N=165 Randomized Prevention

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

Peptic Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT01138969 ↗

Enrolled (actual)

165

Serious AEs

2.4%

Results posted

Feb 2013

Primary outcome: Primary: Recurrent Peptic Ulcer — 1; 9 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: esomeprazole (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Kaohsiung Veterans General Hospital.
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Recurrent Peptic Ulcer	1; 9	—
SECONDARY Peptic Ulcer Bleeding	0; 1	—

Summary

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

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01138969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.