PPI: The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)

Sponsor

Daejeon St. Mary's hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05820048

Collaborator

Jeil Pharmaceutical Co., Ltd. (Industry)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Lansoprazole 15 mg	Phase 4

Detailed Description

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
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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: proton pump inhibitor medication : Lanston capacity : 15mg Number of times : QD period : 6 month Injection path : oral	Drug: Lansoprazole 15 mg Short-term treatment of active duodenal ulcer Short-term treatment of active benign gastric ulcers Thin heat of Helicobacter pylori to prevent recurrence of duodenal ulcer Maintain duodenal ulcer after treatmentLaw Treatment of nonsteroidal anti-inflammatory analgesics-induced gastric ulcers Reducing the risk of developing nonsteroidal anti-inflammatory analgesic-induced gastric ulcers Short-term treatment of gastroesophageal reflux disease Short-term treatment of erosive reflux esophagitis Post-treatment maintenance therapy for erosive reflux esophagitis Pathological hyperdivision, including Zolinger Ellison syndrome Other Names: non-administered army
No Intervention: non-administered army No Intervention

Arm

Intervention/Treatment

Active Comparator: proton pump inhibitor

medication : Lanston capacity : 15mg Number of times : QD period : 6 month Injection path : oral

Drug: Lansoprazole 15 mg

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

Other Names:

non-administered army

No Intervention: non-administered army

No Intervention

Outcome Measures

Primary Outcome Measures

Occurrence of upper gastrointestinal clinical complex [6 month after randomization]
Upper gastrointestinal bleeding with clear origin,upper gastrointestinal bleeding with unclear origin, potential upper gastrointestinal bleeding or perforation

Secondary Outcome Measures

The occurrence of a cardiovascular clinical complex [6 month after randomization]
Combined variables of cardiovascular death, non-fatal myocardial infarction, coronary artery reopening, or ischemic stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)