The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

• Status: Not yet recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daejeon St. Mary's hospital
• Collaborator: Jeil Pharmaceutical Co., Ltd.
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• 19 years of age or older

• Coronary artery disease has one or more of the following

• Stable angina

• unstable angina

• N on ST elevation myocardial infarction

• ST elevation myocardial infarction

• Those who are scheduled to receive or are taking dual antiplatelet therapy including aspirin after PCI trials

• A person whose risk of bleeding falls under an intermediate risk group.

Exclusion Criteria:

• age < 19 years

• known allergy to aspirin and clopidogrel

• A person classified as a high-risk group according to the gastrointestinal risk assessment index

• liver cirrhosis

• known iron deficiency anemia

• recent fibrinolytic therapy

• active cancer

• end-stage renal failure

• life expectancy < 1 year

• co-prescription of NSAIDs, corticosteroid and anticoagulant such as NOAC or warfarin

• pregnancy

• mentally or cognitively disabled people

• mechanical ventilation with endotracheal intubation

• Persons who do not agree to participate in the study

• persons related unequally to investigators (students and employees)