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
Results First Received: December 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Peptic Ulcer
Intervention: Drug: esomeprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
  1. Dates of the recruitment period: From August 2008 to August 2012
  2. Type of location: Kaohsiung Veterans General Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None were excluded following participant enrollment.

Reporting Groups
  Description
Esomeprazole Plus Clopidogrel Group esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
Clopidogrel Group clopidogrel 75 mg qd for 6 months

Participant Flow:   Overall Study
    Esomeprazole Plus Clopidogrel Group     Clopidogrel Group  
STARTED     83     82  
COMPLETED     83     82  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Esomeprazole Plus Clopidogrel Group esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
Clopidogrel Group clopidogrel 75 mg qd for 6 months
Total Total of all reporting groups

Baseline Measures
    Esomeprazole Plus Clopidogrel Group     Clopidogrel Group     Total  
Number of Participants  
[units: participants]
  83     82     165  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     21     46  
>=65 years     58     61     119  
Age  
[units: years]
Mean ± Standard Deviation
  70.6  ± 11.5     73.3  ± 10.7     72.0  ± 11.4  
Gender  
[units: participants]
     
Female     18     23     41  
Male     65     59     124  
Region of Enrollment  
[units: participants]
     
Taiwan     83     82     165  



  Outcome Measures
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1.  Primary:   Recurrent Peptic Ulcer   [ Time Frame: 6 months ]

2.  Secondary:   Peptic Ulcer Bleeding   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The patients without symptoms who refused follow-up endoscopy were regarded as having no recurrent ulcers. Because peptic ulcer may be asymptomatic, the cumulative number of recurrent peptic ulcer might be underestimated in both groups.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ping-I Hsu
Organization: KaohsiungVGH
phone: 886-7-3462121 ext 8233
e-mail: pihsu@isca.vghks.gov.tw


No publications provided by Kaohsiung Veterans General Hospital.

Publications automatically indexed to this study:

Responsible Party: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01138969     History of Changes
Other Study ID Numbers: VGHKS98-CT6-12
Study First Received: June 7, 2010
Results First Received: December 31, 2012
Last Updated: February 2, 2013
Health Authority: Taiwan: Institutional Review Board