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

Primary Purpose

Peptic Ulcer

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

esomeprazole

About this trial

This is an interventional prevention trial for Peptic Ulcer focused on measuring proton pump inhibitor, peptic ulcer, clopidogrel, prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Esomeprazole plus clopidogrel group

Clopidogrel group

Arm Description

esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months

clopidogrel 75 mg qd for 6 months

Outcomes

Primary Outcome Measures

Recurrent Peptic Ulcer

Number of participants with recurrent peptic ulcer within 6 months

Secondary Outcome Measures

Peptic Ulcer Bleeding

participants with peptic ulcer bleeding within 6 months

Full Information

NCT ID

NCT01138969

First Posted

June 7, 2010

Last Updated

September 6, 2015

Sponsor

Kaohsiung Veterans General Hospital.

1. Study Identification

Unique Protocol Identification Number

NCT01138969

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Veterans General Hospital.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peptic Ulcer

Keywords

proton pump inhibitor, peptic ulcer, clopidogrel, prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Esomeprazole plus clopidogrel group

Arm Type

Active Comparator

Arm Description

esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months

Arm Title

Clopidogrel group

Arm Type

No Intervention

Arm Description

clopidogrel 75 mg qd for 6 months

Intervention Type

Drug

Intervention Name(s)

esomeprazole

Other Intervention Name(s)

plavix

Intervention Description

esomeprazole 20 mg qd for 6 months

Primary Outcome Measure Information:

Title

Recurrent Peptic Ulcer

Description

Number of participants with recurrent peptic ulcer within 6 months

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Peptic Ulcer Bleeding

Description

participants with peptic ulcer bleeding within 6 months

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kwok-Hung Lai, MD

Organizational Affiliation

Kaohsiung Veterans General Hospital.

Official's Role

Study Chair

Facility Information:

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

21144850

Citation

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.

Results Reference

derived

Learn more about this trial

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

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