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Completed

NCT Number: NCT02175186

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

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.

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Key information

Conditions

Gastritis Digestive System Diseases Duodenal Diseases Gastroduodenal Ulcer Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, Songpa-Gu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALBIS

Drug

Placebo

Drug

Primary outcomes

  1. Incidence of gastric ulcer

    Time frame: 12weeks

    defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks

Secondary outcomes

  1. Incidence of gastritis

    Time frame: 12weeks

    defined as Modified Lanza Score(MLS) grade 2~4(measured by gastrointestinal endoscopy)at 12weeks

  2. The Endoscopic improvement rate of hemorrhage

    Time frame: 12weeks

    defined as Modified Lanza Score(MLS) grade

  3. The Endoscopic improvement rate of subjective symptom

    Time frame: 12weeks

  4. Total amount of antacid used during study period

    Time frame: 12weeks

Sponsors and collaborators

Lead sponsor

Young-Hak Kim, MD, PhD

Other

Registry information

Official study title

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

Acronym: DAPTALBIS

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 26, 2014
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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