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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01138969
First received: June 7, 2010
Last updated: February 2, 2013
Last verified: February 2013

June 7, 2010
February 2, 2013
August 2008
December 2012   (final data collection date for primary outcome measure)
Recurrent Peptic Ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of participants with recurrent peptic ulcer within 6 months
Rate of Recurrent Peptic Ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
rate of recurrent peptic ulcer within 6 months
Complete list of historical versions of study NCT01138969 on ClinicalTrials.gov Archive Site
Peptic Ulcer Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
participants with peptic ulcer bleeding within 6 months
Rate of Peptic Ulcer Bleeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]
rate of peptic ulcer bleeding within 6 months
Not Provided
Not Provided
 
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Peptic Ulcer
Drug: esomeprazole
esomeprazole 20 mg qd for 6 months
Other Name: plavix
  • Active Comparator: Esomeprazole plus clopidogrel group
    esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
    Intervention: Drug: esomeprazole
  • No Intervention: Clopidogrel group
    clopidogrel 75 mg qd for 6 months
Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011 Mar;140(3):791-8. doi: 10.1053/j.gastro.2010.11.056. Epub 2010 Dec 7. Erratum in: Gastroenterology. 2011 Aug;141(2):778.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01138969
VGHKS98-CT6-12
Yes
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital.
Not Provided
Study Chair: Kwok-Hung Lai, MD Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP