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临床试验/KCT0008181
KCT0008181进行中(未招募)未知

Impact assessment of potassium competitive acid blocker on the gut microbiota of Anginal patients

Kangwon National University Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational Study

入排标准

年龄范围
19(Year) 至 o Limit(—)
性别
All

入选标准

  • 1. A person who is 19 years of age or older as of the date of obtaining written consent
  • 2. Percutaneous coronary intervention (PCI) among patients who were diagnosed with angina and received percutaneous coronary intervention (PCI)
  • Those who agreed to participate in the study within 1 week of receiving
  • 3. Patients who need double antiplatelet therapy (DAPT) for more than 6 months after percutaneous coronary intervention (PCI)
  • 4. A person who voluntarily decided to participate and gave written consent to the consent form for clinical trial subjects
  • 5. A person who agrees to use a medically valid method of contraception (including conditions where pregnancy is medically impossible) during the clinical trial period
  • - Women who are medically unable to conceive can participate in this clinical trial: menopause (more than 24 months of menstruation)
  • cervical), hysterectomy, salpingectomy, bilateral oophorectomy, etc.
  • - Medically valid methods of contraception: intrauterine devices (loop, Mirena), physical barrier methods (male condom, female condom (Femidom)), subcutaneous contraception (Implanon, etc.), long-acting contraceptive injections or salpingectomy and ligation, vasectomy, etc. (only Oral contraceptives cannot be used during this clinical trial, and it is recommended to use double contraception to prevent pregnancy while participating in this trial.)

排除标准

  • 1. Those who cannot complete the questionnaire by themselves
  • 2. Those who have a history of hypersensitivity to proton pump inhibitors and potassium-competitive acid blocker components or benzimidazoles
  • 3. Those who have taken proton pump inhibitor (PPI), H2RA, or P-CAB drugs within 4 weeks of Visit 1 (screening start date)
  • 4. Those who have taken antibiotics, prebiotics, probiotics, or synbiotics within 4 weeks from Visit 1 (screening start date)
  • 5. Those with a history of malignant tumor within the last 5 years based on Visit 1 (screening start date)
  • Those who have been judged for complete remission (CR, pCR) of the tumor and have passed more than 5 years without recurrence from the date of judgment, and the tumor is completely removed through endoscopic gastric mucosal resection (mucosal resection (EMR), submucosal dissection (ESD)) In cases where the disease has occurred, those who have passed more than 3 years without recurrence can be included.
  • 6. Those who have symptoms such as dysphagia, severe dysphagia, bleeding, weight loss, anemia, and bloody stools (except for hemorrhoids), which are warning symptoms” that may presume malignant diseases of the gastrointestinal tract.
  • 7. Patients taking HIV protease inhibitors (atazanavir, nelfinavir) and rilpivirine-containing products
  • 8. Patients with a history of myocardial infarction within 3 months from Visit 1 (screening start date), moderate conduction field
  • Acute (arrhythmia, cardiac block, angular block, 3rd degree atrioventricular block) patients, patients with acute delirium, patients with paralytic ileus
  • 9. Those who showed the following abnormal values in blood chemistry tests within 4 weeks from Visit 1 (screening start date)
  • - BUN, Creatinine > 2 times the organ upper limit of normal
  • - AST, ALT, ALP, total bilirubin > 2 times the upper limit of normal
  • 10. Those with clinically significant disorders in the liver, kidneys, cardiovascular system, respiratory system, endocrine system, and central nervous system
  • 11. Pregnant and lactating women or those who intend to become pregnant
  • 12. Those who participated in other clinical trials within 12 weeks of Visit 1 (screening start date)
  • - However, you have participated in or are participating in a non-interventional study (observational study, questionnaire study, etc.
  • Human clinical trial subjects can participate in this trial.
  • - In addition, in order to participate in other clinical trials, after writing the consent form, administration of clinical trial drugs and screening without treatment
  • Those who are eliminated from the leaning can participate in this test.
  • 13. Patients with a history of alcohol abuse
  • 14. Persons with bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder, and other psychiatric disorders
  • Those who are presumed to have difficulty in collecting Feces samples
  • 15. Continuous use of corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), and anticoagulants during the study period.
  • patients who need to take
  • 16. Patients with contraindications to the use of antithrombotic agents
  • 17. A person who has not obtained the informed consent of the subject and guardian
  • 18. In addition to the above, clinical significance that the investigator judged medically and considered inappropriate for this test
  • person with opinions

研究者

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