Gwangmyeong Si

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet (Filgotinib Maleate) at doses of 100 mg and 200 mg in Korean adults with rheumatoid arthritis or ulcerative colitis. The study focuses on tracking serious adverse events, adverse drug reactions, unexpected events, and other safety-related issues during real-world use following marketing approval in Korea. Participants will not receive any interventions as this is a non-interventional observational study. The study observes patients being treated with Jyseleca according to the Korean approved label, which includes adults with moderately to severely active rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior therapies. The medication may be used alone or with methotrexate in rheumatoid arthritis, but not with biological DMARDs or other JAK inhibitors. During the study, participants will be monitored for safety outcomes such as serious and non-serious adverse events and adverse drug reactions up to 24 weeks after enrollment. Effectiveness measures include changes in disease activity scores for rheumatoid arthritis and ulcerative colitis at 12 and 24 weeks. Researchers will collect and evaluate all safety and efficacy-related information under typical use conditions in Korea.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are evaluating the use of artificial intelligence-driven angiography-based fractional flow reserve (MPFFR) compared to invasive fractional flow reserve (FFR) to guide percutaneous coronary intervention (PCI) in patients with coronary artery disease. This multi-center, randomized controlled trial aims to determine if MPFFR-guided PCI is not worse than the current standard invasive FFR-guided PCI. The study focuses on patients with chronic or acute coronary syndrome and intermediate coronary artery stenosis where the need for PCI is uncertain. The study compares two groups: one guided by MPFFR and the other by invasive FFR. Functionally significant stenosis is defined as MPFFR or FFR values of 0.80 or less. In the MPFFR group, on-site MPFFR values will guide decisions about PCI, while in the invasive FFR group, decisions will be made based on invasive FFR measurements. PCI is recommended for lesions meeting the threshold, but the final decision is left to the operators. Lesions with values above 0.80 will defer PCI. Reasons for not performing PCI when indicated will be recorded. Participants will undergo coronary angiography and physiological assessments using MPFFR or invasive FFR. Researchers will monitor major adverse cardiac events (MACE) one year after the last patient enrollment to compare outcomes. Data on clinical events, PCI decisions, and physiological measures will be collected. The trial seeks to validate MPFFR as a reliable, less invasive alternative to guide PCI, potentially improving patient comfort and procedural efficiency.

Researchers are investigating the outcomes of stopping versus continuing antiplatelet medication in patients with chronic coronary syndrome who have a high risk of bleeding and were treated with drug-coated balloon (DCB) angioplasty. The study focuses on those who have completed a standard dual antiplatelet therapy (DAPT) period of 1 to 3 months followed by at least one year of single antiplatelet therapy without any clinical events. This trial addresses the gap in evidence regarding lifelong antiplatelet use in this particular group, aiming to establish better guidelines for post-treatment care. Participants are randomly assigned one year after their initial DCB angioplasty and standard DAPT treatment to either stop antiplatelet medication or continue lifelong single antiplatelet therapy. For those still on DAPT at randomization, the study protocol either discontinues all antiplatelet drugs or switches to a single antiplatelet agent, chosen by the physician. This open-label, multi-center trial compares these two strategies to determine the best approach for managing antiplatelet therapy in high bleeding risk patients. During the study, participants will be monitored for major bleeding events one year after the last patient enrollment. Researchers will assess safety and efficacy by tracking bleeding incidents classified as BARC types 2, 3, or 5. The trial includes regular follow-ups and evaluations to monitor the participants' health status and treatment outcomes over time, aiming to provide evidence for safer and more effective antiplatelet management after DCB angioplasty in this population.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are conducting a Phase 2b, multicenter, double-blinded, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of Isuzinaxib in adults with diabetic kidney disease (DKD). The study focuses on comparing Isuzinaxib with a placebo in people diagnosed with type 2 diabetes and DKD. It aims to better understand how Isuzinaxib affects kidney function and other health outcomes in this population. Participants will receive oral doses of either Isuzinaxib or placebo once daily. The study includes a dose-ranging design to assess different dosage levels. The treatment period lasts 24 weeks, during which participants will take their assigned medication as directed. The study is double-blinded, meaning neither the participants nor the researchers know who receives the active drug or placebo. During the study, participants will undergo assessments including measurement of urine albumin-creatinine ratio (UACR) over 24 weeks to evaluate kidney function. Researchers will monitor safety through laboratory tests, physical exams, and questionnaires. Participants will be asked to follow dietary management for diabetes and continue stable doses of other medications like ACE inhibitors or angiotensin receptor blockers. The study requires participants to be available and willing to comply with all procedures throughout the 24-week treatment period.

Objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary CTO through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.

This research aims to collect data on the rebound effect and long-term safety of SAT-001, a software device under development to slow myopia progression in children aged 5 to less than 9 years. The study focuses on pediatric patients who completed a previous trial evaluating this device, as myopia progression can continue for over two years and may accelerate after stopping treatment. Understanding this rebound effect is important for developing effective treatment strategies for childhood myopia. This multi-center, open-label, controlled observational extension study follows 40 participants from both treatment and control groups of the prior trial. Participants will continue wearing single vision spectacles, the conventional treatment for myopia, during the 6-month extension period after completing the original study. The trial excludes those with less than 70% compliance in the previous study and does not provide other myopia treatments besides glasses. During the 6-month follow-up, researchers will measure changes in the refractive error of the eye and axial length at 12 and 24 weeks compared to baseline to assess the rebound effect and safety of SAT-001. Participants and their guardians will provide informed consent, and safety and long-term outcomes will be closely monitored throughout the study duration.

Researchers are evaluating whether the 2-year chance of major adverse cardiac events differs between two methods of guiding Percutaneous Coronary Intervention (PCI) in patients with Left Main Coronary Artery disease. The study compares Fractional Flow Reserve (FFR)-guided PCI to angiography-guided PCI to better understand treatment decision-making for this heart condition. Participants will be divided into two groups receiving either FFR-guided PCI or angiography-guided PCI. Both are procedures used to treat significant narrowing in the left main coronary artery. The study involves monitoring each participant's health and event occurrences over a two-year period. Throughout the study, all participants will be closely monitored until their last scheduled visit, which may occur up to two years after treatment. Researchers will check for any major cardiac events during this time to assess differences between the two treatment approaches. The primary measure is the combined rate of these events over the two years.