Effect of rebamipide in coronary artery disease patients with dual antiplatelet induced gastrointestinal tract injury

Phase 3

Recruiting

• Conditions: Coronary artery disease patients with dual antiplatelet induced gastrointestinal tract injury; Antiplatelet induced enteropathy; Aspirin induced enteropathy; Rebamipide

• Registration Number: TCTR20180104001
• Lead Sponsor: Thai Otsuka Pharmaceutical Co,Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-04
• Study Completion: 2018-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anemia Day 0 (at baseline), End of month 1, End of month 2, End of month 3 , End of month 6 Hemoglobin level

Secondary Outcome Measures

Name	Time	Method
Enteropathy Day 0 (at baseline), End of month 6 finding on video capsule endoscopy