Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
NCT ID: NCT02175186
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
47 participants
INTERVENTIONAL
2015-01-21
2019-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALBIS
Albis Tab 2 tab twice a day 12weeks
ALBIS
Placebo
placebo Tab 2 tab twice a day 12weeks
Placebo
Interventions
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ALBIS
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Young-Hak Kim, MD, PhD
OTHER
Responsible Party
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Young-Hak Kim, MD, PhD
MD,PhD
Principal Investigators
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Young-Hak Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, Songpa-Gu, South Korea
Countries
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Other Identifiers
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AMCCV 2014-05
Identifier Type: -
Identifier Source: org_study_id
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