Coronary artery disease patients with dual antiplatelet induced gastrointestinal tract injury Aspirin induced enteropathy Antiplatelet induced enteropathy Rebamipide
Conditions
Interventions
Rebamipide can stimulate prostaglandin production,
increase mucin and bicarbonate production to counteract with the effect of antiplatelet induced gastrointestinal tract damage.
Take rebamipide 1 tablet tid pc for 6 months,Take 1 tablet tid pc for 6 m
Experimental Drug,Placebo Comparator Drug
Rebamipide,Placebo
Sponsors
Thai Otsuka Pharmaceutical Co,Ltd
The Gastroenterological Association of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old 2. Have been treated with dual antiplatelet for at least 3 months and received proton pump inhibitors to prevent UGIB. 3. Dual antiplatelet defined as aspirin plus any thienopyridine group 4. Newly developed clinically significant anemia (decrease ≥ 2 g /dL in hemoglobin and/or ≥10% in hematocrit) 5. Consent for EGD/colonoscopy 6. Consent for VCE
Exclusion criteria
Exclusion criteria: 1. Patients receiving gastroprotective drug before enrollment 2. Patients with a hemoglobin level less than 7 g / dl 3. EGD discovered lesions that can explain blood loss in upper gastrointestinal tract including o Cancer o Esophagitis LA grade C-D o Gastroduodenal erosions more than 5-10 lesions o Gastroduodenal ulcers (one ulcer if size > 1 cm or 2 ulcers if size 0.5-1 cm) o Angiectasia (one lesion if larger than 7 mm, two lesions if size 5-7 mm, or more than four lesions) o Polyps larger than 1.5 cm or with sign of recent bleeding 4. Colonoscopy discovered lesions that can explain blood loss in colon including o Cancer o Polyps larger than 1.5 cm or with sign of recent bleeding o Angiectasia (one lesion if larger than 7 mm, two lesions if size 5-7 mm, or more than four lesions) o Active colitis o Ulcer larger than 1 cm 5. Patients with anemia from chronic kidney disease, gynecologic bleeding or hematologic disease. 6. Patients with active and overt gastrointestinal bleeding. 7. Patients with gastrointestinal obstruction. 8. Patients with dysphagia. 9. Patients with previous gastrointestinal tract surgery 10. Patients with a history of allergy to study drug. 11. Patients with significant liver disease. 12. Patients with kidney disease (eGFR < 30 mL/min/1.73m2) 13. Pregnancy 14. Breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anemia Day 0 (at baseline), End of month 1, End of month 2, End of month 3 , End of month 6 Hemoglobin level | — |
Secondary
| Measure | Time frame |
|---|---|
| Enteropathy Day 0 (at baseline), End of month 6 finding on video capsule endoscopy | — |
Countries
Thailand
Contacts
Public ContactSiripa Puasripun
Department of Internal Medicine, Faculty of medicine, Chiang Mai university
Outcome results
None listed