Clinical Efficacy of rabeprazole in patients treated with dual antiplatelet agents including potent P2Y12 inhibitors after percutaneous coronary intervention for acute coronary syndrome

Not Applicable

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0008344
• Lead Sponsor: Yonsei University Yongin Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients between 19 and 80 years of age.
2. Among patients diagnosed with acute coronary syndrome and who have undergone percutaneous coronary intervention(PCI), those who have agreed to participate in the study
3. Patients who need to take dual antiplatelet agents including potent P2Y12 inhibitor (Prasugrel, ticagreler) for more than 8 weeks after PCI.
4. A person who voluntarily agreed to participate in this clinical study.
5. A person who has agreed to use medically validated contraception methods (including medically impossible pregnancy conditions) during the clinical trial period.

Exclusion Criteria

1) A person who cannot fill out a questionnaire on his/her own.
2) Patients who overreact to heparin, aspirin, prasugrel,ticagreler, or proton pump inhibitor.
3) A person who underwent surgery that may affect gastric acid secretion, such as upper gastrointestinal resection, gastric acid secretion suppression, or gastric mucosal resection.
4) People who diagnosed with Zollinger-Ellison syndrome, inflammatory diseases (inflammatory bowel disease such as Crohn's disease or ulcerative colitis, pancreatitis, etc.).
5) Where upper gastrointestinal endoscopy is deemed inappropriate, or a person with gastrointestinal bleeding, active peptic ulcer, or malignant tumor.
6) A person who has a history of malignant tumors within 5 years. However, it may include those who have been diagnosed with complete remission of the tumor for more than 5 years without recurrence from the date of judgment and those who have passed more than 3 years without recurrence if the tumor is completely removed through endoscopic gastric mucosal resection or submucosal dissection.
7) Those who have taken proton pump inhibitors or H2RA, P-CAB-based drugs within two weeks, or those who have a history of gastrointestinal bleeding and must take proton pump inhibitors.
8) Patients with a Left ventricular systolic function of 30% or less on echocardiography.
9) Subjects with a life expectancy of less than 12 months.
10) A person who has shown clinically significant impairment in the liver, kidney, cardiovascular system, respiratory system, endocrine system, and central nervous system.
11) Pregnant women and lactating women or those who intend to conceive.
12) Patients with contraindication of administering aspirin, praschgrel, and ticagreler.
13) Patients with contraindication of administering proton pump inhibitors.
14) Patients who has clinical significant findings that are medically judged by the physician and deemed inappropriate for this study

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified lanza score grade on upper gastrointestinal endoscopy

Secondary Outcome Measures

Name	Time	Method
Scores of gastrointestinal symptoms through questionnaires (NDI-K);Proportion of patients with modified lanza score 4-5;Gastrointestinal bleeding (BARC type 2,3,5);Platelet (P2Y12) reaction unit (PRU);Major adverse cardiac events for 2 months (Composite events of death, myocardial infarction, stent thrombosis and target lesion revascularization)