Clinical trial NCT05820048: The Efficacy and Safty of Proton Pump Inhibitor (Lansoprazole)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: proton pump inhibitor
percutaneous coronary intervention
gastrointestinal bleeding of moderate risk
dual anti-platelet drugs
Lead sponsor: Daejeon St. Mary's hospital
Sponsor class: OTHER
Collaborators: name: Jeil Pharmaceutical Co., Ltd.
First posted: 2023-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Eligibility 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)

Primary outcomes:
measure: Occurrence of upper gastrointestinal clinical complex
timeFrame: 6 month after randomization
Secondary outcomes:
measure: The occurrence of a cardiovascular clinical complex
timeFrame: 6 month after randomization
Other outcomes:
Locations:
Study officials:
affiliation: Cardiovascular Center, Mary's Hospital,64, Daeheung-ro, Jung-gu, Daejeon, Republic of Korea
name: DaeWon Kim
role: PRINCIPAL_INVESTIGATOR
References:
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