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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02175186

Acronym

DAPTALBIS

Enrollment

Registered

2014-06-26

Start date

2015-01-21

Completion date

2019-01-08

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastritis, Gastroduodenal Ulcer

Keywords

Gastritis, Gastroduodenal Ulcer, Percutaneous Coronary Revascularization, Dual Antiplatelet Therapy

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.

Interventions

DRUGALBIS

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026