Gwangmyeong Si

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet Filgotinib Maleate 100 mg and 200 mg in Korean participants using it in real-world conditions. The study focuses on monitoring serious and non-serious adverse events and drug reactions, including unexpected ones, as well as changes in disease activity scores related to rheumatoid arthritis and ulcerative colitis. Participants prescribed Jyseleca according to Korean approved therapeutic indications will be observed without additional intervention. They will be followed for up to 24 weeks or until they stop treatment due to adverse events or other reasons. The study includes adults with rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior treatments. During the study, researchers will track adverse events and reactions from enrollment through 24 weeks. They will also measure changes in disease activity scores at baseline, week 12, and week 24. Participants will have regular monitoring visits as part of their usual care, with data collected about safety and treatment effects. The total participation time is up to 24 weeks.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating the use of an artificial intelligence-driven angiography-based fractional flow reserve MPFFR compared with 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 inferior to invasive FFR-guided PCI in terms of clinical outcomes. The study addresses limitations of current FFR methods, such as the need for pressure wires and drug-induced hyperemia, by testing a faster, automated AI-based alternative. Participants will be randomly assigned to one of two groups the MPFFR-guided PCI group or the invasive FFR-guided PCI group. In the MPFFR group, AI software analyzes angiographic images to measure blood flow reserve without manual segmentation, with PCI recommended for lesions showing MPFFR values of 0.80 or less. In the invasive FFR group, a pressure wire and drugs are used to measure FFR, with PCI recommended for lesions with FFR values of 0.80 or less. Decisions to perform PCI are made by the treating doctors, and reasons for deferral are recorded. During the study, participants will undergo diagnostic coronary angiography followed by the assigned FFR measurement method. Researchers will monitor major adverse cardiac events one year after the last patient enrolls, along with other outcomes such as death, heart attacks, revascularization procedures, and procedure-related measures. The trial includes detailed follow-up to assess safety and effectiveness, with data collected on procedure times, contrast use, and device performance throughout the study period.

Researchers are evaluating the clinical outcomes of stopping versus continuing antiplatelet therapy in patients with chronic coronary syndrome who have a high risk of bleeding HBR. The study focuses on patients treated with drug-coated balloon DCB angioplasty and standard dual antiplatelet therapy DAPT for 1 to 3 months, followed by maintenance of a single antiplatelet agent for at least one year. This trial explores whether lifelong antiplatelet therapy is necessary after DCB angioplasty in this population, as current evidence mainly involves patients with drug-eluting stents and acute conditions. Participants will be randomly assigned after one year from their DCB angioplasty procedure and standard DAPT. One group will discontinue antiplatelet therapy at randomization, including those still on DAPT, while the other group will continue lifelong antiplatelet monotherapy, either aspirin or clopidogrel, based on physician choice. The study compares these two approaches to better understand post-treatment management in high bleeding risk patients. During the trial, participants will be closely monitored for major bleeding events and other cardiovascular outcomes over one year following the last patient enrollment. Researchers will assess safety and clinical events such as myocardial infarction, death, and revascularization procedures. The study also includes ongoing evaluation of patient status to ensure adherence and track any complications or benefits from the different antiplatelet strategies.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of Isuzinaxib compared to a placebo in adults with diabetic kidney disease DKD. This Phase 2b study is randomized, double-blind, placebo-controlled, and dose-ranging, aiming to better understand how Isuzinaxib works in this patient population. The study is sponsored by Aptabio Therapeutics, Inc. and focuses on managing DKD through medication evaluation. Participants will be randomly assigned to one of three groups to receive either 400 mg of Isuzinaxib, 200 mg of Isuzinaxib, or a placebo. All treatments are taken orally once daily. The study is multicenter and includes dose-ranging to assess different levels of Isuzinaxib. The treatment period lasts 24 weeks, during which participants will be closely monitored. During the study, participants will undergo regular assessments including measurements of urine albumin-creatinine ratio UACR over 24 weeks, estimated glomerular filtration rate eGFR, and safety evaluations such as adverse event monitoring and pharmacokinetic analyses. Participants are expected to comply with study procedures, dietary management for diabetes, and use birth control if applicable. The total duration involves screening and the 24-week treatment period with safety and efficacy follow-up.

Researchers are studying patients with chronic total occlusion CTO of the coronary artery to compare two different procedural approaches the antegrade and retrograde methods. The study aims to analyze clinical, anatomical, and procedural differences between patients who underwent each approach, evaluate the success rates and complication patterns, and assess long-term outcomes after successful procedures. It also seeks to identify factors that influence the need for the retrograde approach and prognostic factors related to long-term results. Participants are those who have at least one CTO lesion in an epicardial coronary artery with a diameter of 2.5 mm or more and exhibit symptoms of angina or confirmed myocardial ischemia. The study observes patients who underwent either the antegrade or retrograde percutaneous coronary intervention PCI approach. It is an observational study without experimental interventions, focusing on detailed clinical and procedural data collection. The study follows patients for long-term outcomes, with primary measures assessed at 12 months post-PCI and secondary measures annually up to five years. During the study, participant data including procedure success, occurrence of death, myocardial infarction, and target vessel revascularization or reocclusion are tracked. Safety and effectiveness outcomes are evaluated through clinical follow-ups and medical records review. The studys total duration extends up to five years to monitor long-term performance and complications after PCI. Participants provide informed consent and agree to follow-up plans approved by institutional review boards.

This research focuses on children aged 5 to less than 9 years with myopia. It aims to study the rebound effect, where myopia progression may accelerate after stopping treatment, and to evaluate the long-term safety of SAT-001, a Software as a Medical Device designed to slow myopia progression in pediatric patients. This study serves as an extension to a previous trial that initially tested SAT-001s effects on myopia progression. Participants from the earlier trial, including both those who received SAT-001 plus single vision spectacles and those who only wore spectacles, will be followed for 6 months. During this extension phase, all participants continue wearing single vision spectacles but will no longer receive SAT-001 treatment. The study will monitor changes in eye measurements to assess any rebound in myopia and to observe safety outcomes after stopping SAT-001. Childrens eye health will be regularly evaluated through measurements of spherical equivalent refractive error and axial length at baseline, 12 weeks, and 24 weeks. Researchers will also observe any adverse effects related to stopping SAT-001. The total participation time in this extension study is 6 months following the completion of the initial trial, allowing for close monitoring of myopia progression and safety.

Researchers are evaluating whether the risk of major adverse cardiac events over two years differs between two methods of guiding Percutaneous Coronary Intervention PCI in patients with Left Main Coronary Artery LMCA disease. The study compares Fractional Flow Reserve FFR-guided PCI and angiography-guided PCI to understand which approach may better influence treatment decisions and outcomes for this condition. Participants will be randomly assigned to receive either FFR-guided PCI or angiography-guided PCI. Both procedures involve using drug-eluting stents to treat significant LMCA disease and may include patients with other coronary artery diseases. The study will monitor participants for two years after their procedure, capturing various heart-related events and treatment outcomes during this period. During the two-year follow-up, participants will have clinical visits and assessments to track events such as death, heart attacks, hospitalizations, repeat procedures, stroke, bleeding, and stent problems. Researchers will also evaluate hospital stay length, procedure details, heart function, quality of life related to angina and health, and medication use. The study aims to provide comprehensive information on the safety and effectiveness of both PCI guidance strategies over this time frame.