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

Young-Hak Kim, MD, PhD

Status and phase

Completed

Phase 4

Conditions

Gastritis

Gastroduodenal Ulcer

Treatments

Drug: ALBIS

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02175186

AMCCV 2014-05

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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