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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole plus clopidogrel group | Active Comparator | esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months |
|
| Clopidogrel group | No Intervention | clopidogrel 75 mg qd for 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole | Drug | esomeprazole 20 mg qd for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Peptic Ulcer | Number of participants with recurrent peptic ulcer within 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peptic Ulcer Bleeding | participants with peptic ulcer bleeding within 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwok-Hung Lai, MD | Kaohsiung Veterans General Hospital. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21144850 | Derived | 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. |
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None were excluded following participant enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole Plus Clopidogrel Group | esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months |
| FG001 | Clopidogrel Group | clopidogrel 75 mg qd for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole Plus Clopidogrel Group | esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months |
| BG001 | Clopidogrel Group | clopidogrel 75 mg qd for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Peptic Ulcer | Number of participants with recurrent peptic ulcer within 6 months | Intention to treat | Posted | Number | participants | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esomeprazole Plus Clopidogrel Group | esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute myocardial infarct | Cardiac disorders | thrombotic events | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| unstable angina | Cardiac disorders | thrombotic events | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ping-I Hsu | KaohsiungVGH | 886-7-3462121 | 8233 | pihsu@isca.vghks.gov.tw |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Peptic Ulcer Bleeding | participants with peptic ulcer bleeding within 6 months | Intention to treat | Posted | Number | participants | 6 months |
|
|
|
| 2 |
| 83 |
| 1 |
| 83 |
| EG001 | Clopidogrel Group | clopidogrel 75 mg qd for 6 months | 2 | 82 | 1 | 82 |
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| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |