Overview

The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

Status:
Not yet recruiting
Trial end date:
2025-07-31
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Daejeon St. Mary's hospital
Collaborator:
Jeil Pharmaceutical Co., Ltd.
Treatments:
Dexlansoprazole
Lansoprazole