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The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

NCT05820048 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-19

No results posted yet for this study

Summary

Among patients who performed percutaneous coronary intervention (PCI) in patients with coronary artery disease (CAD), enrollment is performed in patients with moderate risk in gastrointestinal risk assessment indicators. After obtaining the consent form, patients are randomly assigned to the gastric acid secretion inhibitor group and the non-dose group.

Researchers and subjects proceed with the treatment group assignment, treatment-group assignment uses a random number table and the assigned drug is disclosed. Random checks are generated by statisticians and managed by the researchers.

In the test group, the incidence of gastrointestinal clinical events in DAPT patients is expected to be low while taking PPI, but there is a burden of PPI costs. In the case of the control group, the burden of PPI costs is reduced, but there is a possibility that the incidence of clinical events may occur, although it is a small number. Subjects in the test group will take DAPT for at least 6 months from the time of registration, and NSAIDs drugs or steroids and NOAC or warfarin should be prohibited as combination taboo drugs when participating in the study. Data will be collected during normal medical procedures and will be checked through an endoscope in case of upper gastrointestinal bleeding

Conditions

Interventions

DRUG

Lansoprazole 15 mg

1. Short-term treatment of active duodenal ulcer 2. Short-term treatment of active benign gastric ulcers 3. Thin heat of Helicobacter pylori to prevent recurrence of duodenal ulcer 4. Maintain duodenal ulcer after treatmentLaw 5. Treatment of nonsteroidal anti-inflammatory analgesics-induced gastric ulcers 6. Reducing the risk of developing nonsteroidal anti-inflammatory analgesic-induced gastric ulcers 7. Short-term treatment of gastroesophageal reflux disease 8. Short-term treatment of erosive reflux esophagitis 9. Post-treatment maintenance therapy for erosive reflux esophagitis 10. Pathological hyperdivision, including Zolinger Ellison syndrome

Sponsors & Collaborators

  • Jeil Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Daejeon St. Mary's hospital

    lead OTHER

Principal Investigators

  • DaeWon Kim · Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-04-01
Completion
2025-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05820048 on ClinicalTrials.gov