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

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ClinicalTrials.gov Identifier: NCT01138969
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : February 4, 2013
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

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

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: esomeprazole Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding
Study Start Date : August 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Esomeprazole plus clopidogrel group
esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
Drug: esomeprazole
esomeprazole 20 mg qd for 6 months
Other Name: plavix
No Intervention: Clopidogrel group
clopidogrel 75 mg qd for 6 months



Primary Outcome Measures :
  1. Recurrent Peptic Ulcer [ Time Frame: 6 months ]
    Number of participants with recurrent peptic ulcer within 6 months


Secondary Outcome Measures :
  1. Peptic Ulcer Bleeding [ Time Frame: 6 months ]
    participants with peptic ulcer bleeding within 6 months



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138969


Locations
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Study Chair: Kwok-Hung Lai, MD Kaohsiung Veterans General Hospital.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ping-I (William) Hsu, M.D., Chief, Gastroenterology Division, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01138969     History of Changes
Other Study ID Numbers: VGHKS98-CT6-12
First Posted: June 8, 2010    Key Record Dates
Results First Posted: February 4, 2013
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
proton pump inhibitor
peptic ulcer
clopidogrel
prevention

Additional relevant MeSH terms:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Clopidogrel
Ticlopidine
Esomeprazole
Proton Pump Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents