Peptic Ulcer
Conditions
Keywords
proton pump inhibitor, peptic ulcer, clopidogrel, prevention
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.
Interventions
DRUGesomeprazole
esomeprazole 20 mg qd for 6 months
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Peptic Ulcer | 6 months | Number of participants with recurrent peptic ulcer within 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peptic Ulcer Bleeding | 6 months | participants with peptic ulcer bleeding within 6 months |
Countries
Taiwan
Participant flow
Recruitment details
1. Dates of the recruitment period: From August 2008 to August 2012 2. Type of location: Kaohsiung Veterans General Hospital
Pre-assignment details
None were excluded following participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole Plus Clopidogrel Group esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months | 83 |
| Clopidogrel Group clopidogrel 75 mg qd for 6 months | 82 |
| Total | 165 |
Baseline characteristics
| Characteristic | Clopidogrel Group | Esomeprazole Plus Clopidogrel Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 58 Participants | 119 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 25 Participants | 46 Participants |
| Age, Continuous | 73.3 years STANDARD_DEVIATION 10.7 | 70.6 years STANDARD_DEVIATION 11.5 | 72.0 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment Taiwan | 82 participants | 83 participants | 165 participants |
| Sex: Female, Male Female | 23 Participants | 18 Participants | 41 Participants |
| Sex: Female, Male Male | 59 Participants | 65 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 83 | 1 / 82 |
| serious Total, serious adverse events | 2 / 83 | 2 / 82 |
Outcome results
Primary
Recurrent Peptic Ulcer
Number of participants with recurrent peptic ulcer within 6 months
Time frame: 6 months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole Plus Clopidogrel Group | Recurrent Peptic Ulcer | 1 participants |
| Clopidogrel Group | Recurrent Peptic Ulcer | 9 participants |
Secondary
Peptic Ulcer Bleeding
participants with peptic ulcer bleeding within 6 months
Time frame: 6 months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole Plus Clopidogrel Group | Peptic Ulcer Bleeding | 0 participants |
| Clopidogrel Group | Peptic Ulcer Bleeding | 1 participants |