Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Chulalongkorn Memorial Hospital

Criteria

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