Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT

Phase 2

Completed

• Conditions: Duodenal Ulcer Induced by Anti-platelet Agent; Gastric Ulcer Induced by Anti-platelet Agent
• Interventions: Drug: Placebo; Drug: Repamipide

• Registration Number: NCT02166008
• Lead Sponsor: King Chulalongkorn Memorial Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-18
• Study Start: 2014-07
• Primary Completion: 2017-06
• Study Completion: 2018-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide.
Repamipide	Repamipide	Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred

Primary Outcome Measures

Name	Time	Method
number of peptic ulcer by end0scopy	1 year

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Patumwan, Bangkok, Thailand