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

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ClinicalTrials.gov Identifier: NCT02175186
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Young-Hak Kim, MD, PhD, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Gastritis Gastroduodenal Ulcer Drug: ALBIS Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Actual Study Start Date : January 20, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: ALBIS
Albis Tab 2 tab twice a day 12weeks
Drug: ALBIS
Placebo Comparator: Placebo
placebo Tab 2 tab twice a day 12weeks
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175186


Contacts
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Contact: Young-Hak Kim, MD mdyhkim@amc.seoul.kr
Contact: Eun-Young Lee, CRC cvcrc21@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-Gu, Korea, Republic of
Contact: Young-Hak Kim, MD, PhD    82-2-3010-3955    mdyhkim@amc.seoul.kr   
Principal Investigator: Young-Hak Kim, MD,PhD         
Sponsors and Collaborators
Young-Hak Kim, MD, PhD
Investigators
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Principal Investigator: Young-Hak Kim, MD Asan Medical Center

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Responsible Party: Young-Hak Kim, MD, PhD, MD,PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02175186     History of Changes
Other Study ID Numbers: AMCCV 2014-05
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Keywords provided by Young-Hak Kim, MD, PhD, Asan Medical Center:
Gastritis
Gastroduodenal Ulcer
Percutaneous Coronary Revascularization
Dual Antiplatelet Therapy

Additional relevant MeSH terms:
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Gastritis
Peptic Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases