Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.

Official Title
-----------------
Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

Conditions
-----------------
Gastritis, Gastroduodenal Ulcer

Intervention / Treatment
-----------------
* Drug: ALBIS
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20 and 80 years Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy mild gastrointestinal symptom Creatinen in blood ≤ 3mg/dl BUN ≤ 50mg/dl Birilubin ≤ 3mg/dl AST and ALT ≤ 80U/L Exclusion Criteria: Pregnant or breast feeding History of Stomach or esophagus surgery Peptic ulcer or reflux esophagitis Zollinger-Ellison syndrome or primary esophageal motility disorders Malignant tumor Bleeding tendency or coagulopathy Contraindication of ALBIS Long term use of aspirin or P2Y12 receptor antagonist within 1month Patients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed) Terminal patient

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALBIS<br>Albis Tab 2 tab twice a day 12weeks | Drug: ALBIS<br> <br> |
| Placebo Comparator: Placebo<br>placebo Tab 2 tab twice a day 12weeks | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gastric ulcer | defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gastritis | defined as Modified Lanza Score(MLS) grade 2 4(measured by gastrointestinal endoscopy)at 12weeks | 12weeks | 
| The Endoscopic improvement rate of hemorrhage | defined as Modified Lanza Score(MLS) grade | 12weeks | 
| The Endoscopic improvement rate of subjective symptom |  | 12weeks | 
| Total amount of antacid used during study period |  | 12weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastritis, Gastroduodenal Ulcer, Percutaneous Coronary Revascularization, Dual Antiplatelet Therapy