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Completed

NCT Number: NCT01138969

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

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

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

esomeprazole 20 mg qd for 6 months

Other names: plavix

Primary outcomes

  1. Recurrent Peptic Ulcer

    Time frame: 6 months

    Number of participants with recurrent peptic ulcer within 6 months

Secondary outcomes

  1. Peptic Ulcer Bleeding

    Time frame: 6 months

    participants with peptic ulcer bleeding within 6 months

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2010
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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