Duodenal Ulcer Induced by Anti-platelet Agent, Gastric Ulcer Induced by Anti-platelet Agent
Conditions
Keywords
Repamipide, Dual antiplatelet, Peptic ulcer
Brief summary
* Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents * Study Design: Single center, double-blind, randomized-control trial study * Study drug: Repamipide vs. placebo * Assessment criteria The patients will be discharged from the study when one of the followings occurred, 1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up 2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy 3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy 4. Evidence of recurrent myocardial infarction from stent thrombosis
Interventions
DRUGRepamipide
DRUGPlacebo
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 year-old 2. Had cardiovascular disease which needed clopidogrel and aspirin 3. Stable enough for gastroscopy
Exclusion criteria
1. Gastroscopy revealed peptic ulcer 2. Had contraindication for gastroscopy 3. Not allowed for gastroscopy by cardiologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of peptic ulcer by end0scopy | 1 year |
Countries
Thailand
Outcome results
None listed