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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
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Peptic Ulcer
Intervention: Drug: esomeprazole

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 83   82   165 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   25   21   46 
>=65 years   58   61   119 
[Units: Years]
Mean (Standard Deviation)
 70.6  (11.5)   73.3  (10.7)   72.0  (11.4) 
[Units: Participants]
Female   18   23   41 
Male   65   59   124 
Region of Enrollment 
[Units: Participants]
Taiwan   83   82   165 

  Outcome Measures

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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Submitted: June 7, 2010
First Posted: June 8, 2010
Results First Submitted: December 31, 2012
Results First Posted: February 4, 2013
Last Update Posted: September 9, 2015