NCT05820048

The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

The Efficacy and Safety of Proton Pump Inhibitor ( in Patients With Moderate Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary: A Randomised, Open ,Compared With Control

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Daejeon St. Mary's hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

1. Purpose : This study compares gastrointestinal and cardiovascular events with coronary artery disease (CAD) patients who underwent percutaneous coronary angioplasty in patients with moderate gastrointestinal bleeding risk with use of dual antiplatelet drugs (DAPT), especially controversial use of prophylactic acid secretion inhibitors, and attempts to confirm the effectiveness and safety of gastric acid secretion inhibitors 2. Background : DPAT is a standard treatment in patients with CAD with percutaneous coronary intervention (PCI). However, it is important to consider the GI bleeding risk when using DAPT and to determine whether Proton Pump Inhibitor (PPI) should be prescribed to prevent such accidents. DAPT, or aspirin and P2Y12 receptor inhibitor, complementarily reduce platelet activation and aggregation and consequently reduce the progression of coronary thrombosis. We have reported whether PPI use is associated with ischemic events or mortality in patients with DAPT up to date, but we have shown conflicting results depending on the type of study conducted. Observational studies generally show that PPI increases all-cause and cardiovascular mortality, angina and stroke, while RCT studies show that it does not. This difference can be explained by the selection bias. This is because observational studies attempt to reduce selective bias through correction of basic patient characteristics, but unmeasured differences in underlying variables continue to affect the results. 3. method : Among patients who performed PCI in patients with 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

• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-04-01
• Completion: 2025-07-31
• First posted: 2023-04-19
• Last updated: 2023-04-19