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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding

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

Detailed Summary: 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.
Sponsor: Kaohsiung Veterans General Hospital.

Current Primary Outcome: Recurrent Peptic Ulcer [ Time Frame: 6 months ]

Original Primary Outcome: Rate of Recurrent Peptic Ulcer [ Time Frame: 6 months ]

Current Secondary Outcome: Peptic Ulcer Bleeding [ Time Frame: 6 months ]

Original Secondary Outcome: Rate of Peptic Ulcer Bleeding [ Time Frame: 6 months ]

Information By: Kaohsiung Veterans General Hospital.

Dates:
Date Received: June 7, 2010
Date Started: August 2008
Date Completion:
Last Updated: September 6, 2015
Last Verified: September 2015