NCT02166008

Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: King Chulalongkorn Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastric Ulcer Induced by Anti-platelet Agent
• Duodenal Ulcer Induced by Anti-platelet Agent

Interventions

Type	Name	Description
DRUG	Repamipide
DRUG	Placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2014-06-18
• Last updated: 2019-02-27

Locations

1 site across 1 country: Thailand