Jangsu

This research aims to evaluate the pharmacokinetic interaction, safety, and tolerability of two investigational drugs, UIC202601 and UIC202602, in healthy adult volunteers aged 19 to 54 years. The study is a randomized, open-label, two-arm, two-period, multiple-dose trial designed to understand how these drugs interact when taken alone or in combination. Participants receive UIC202601 alone, UIC202602 alone, or both drugs together at a dose of 1 or 2 tablets per day respectively, over 7 days. The study uses a crossover model where participants receive each treatment in separate periods, allowing researchers to compare drug effects within the same individual. During the trial, participants undergo thorough medical evaluations including blood tests, physical exams, and ECGs to monitor safety and drug levels. The primary measures are the drug concentrations in the blood over 24 hours after steady state dosing. The total study duration includes screening, treatment periods, and follow-up to assess tolerability and pharmacokinetics until September 2026.

Researchers are evaluating two different strategies for complete revascularization in patients with significant coronary artery disease CAD who are undergoing percutaneous coronary intervention PCI with drug-eluting stents DES. The study compares quantitative coronary angiography QCA-guided anatomic complete revascularization and fractional flow reserve FFR-guided physiologic complete revascularization. This prospective, multicenter, randomized trial includes patients with symptoms or evidence of myocardial ischemia and specific stenotic lesions in major coronary arteries. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with at least 50% diameter stenosis, or the FFR-guided group, where PCI targets lesions with FFR values of 0.80 or less. Imaging guidance during PCI is optional but left to the operators discretion, while routine high-pressure post-dilation is recommended. The study involves an initial procedure with possible staged procedures as needed. Participants will be followed clinically at 1, 6, and 12 months, and then up to 5 years after the initial procedure. Assessments include tracking death, myocardial infarction, unplanned repeat revascularization, bleeding, rehospitalization, and self-rated health. The study aims to collect data on these outcomes to compare the two revascularization strategies in terms of safety, efficacy, and cost-effectiveness over both short- and long-term periods.

This research aims to gain approval in Korea for camrelizumab SHR-1210, a drug already approved in China, for treating patients with advanced or metastatic non-squamous non-small cell lung cancer NSCLC that is EGFRALK wild-type. The study focuses on patients with Stage IIIB-IV NSCLC to confirm camrelizumabs effectiveness in the Korean population by comparing tumor responses. Participants will receive camrelizumab combined with pemetrexed and carboplatin as first-line treatment. Camrelizumab 200 mg is given intravenously on Day 1 of each 3-week cycle for at least 8 cycles 24 weeks. Pemetrexed and carboplatin are also administered intravenously on Day 1 of each cycle, with carboplatin given for 4-6 cycles. This treatment plan aims to study the overall tumor response and progression. Throughout the study, participants undergo tumor assessments using RECIST criteria at regular intervals to measure the best overall response. Additional outcomes include progression-free survival, overall survival, objective response rate, and disease control rate over various time points. Safety and lab tests are performed before treatment, and participants are monitored through the treatment period and up to 6 months after the last visit, with an expected survival of at least 3 months.

Researchers are evaluating the effects of aspirin and high-intensity statin therapy in people with severe coronary calcification, defined as a coronary calcium score of 300 or higher. The trial aims to understand how these treatments may help prevent atherosclerotic cardiovascular disease ASCVD events in this population. This phase 4, randomized, open-label trial uses a factorial design to assess both aspirin use and statin intensity. Participants are assigned to one of four groups aspirin 100 mgday with high-intensity statin therapy no aspirin with high-intensity statin therapy no aspirin with guideline-directed statin therapy or aspirin 100 mgday with guideline-directed statin therapy. Statin intensity follows the 2026 ACCAHA Guideline on the Management of Dyslipidemia. The study treatment lasts for 3 years, during which participants take the assigned medications. Throughout the trial, participants will be monitored for cardiovascular events and safety outcomes over 3 years. The main outcome is the rate of a composite of ASCVD events. Secondary outcomes include rates of individual cardiovascular events, death from any cause, hospitalization for heart failure, major bleeding, and safety endpoints. Participants will provide informed consent and follow the study protocol with scheduled clinical follow-ups to assess these outcomes.

Researchers are evaluating the best treatment for patients with antiphospholipid syndrome APS who have experienced an ischemic stroke. APS is linked to stroke, but the best way to prevent further strokes in these patients is unclear. Current guidelines suggest warfarin, but these are based on older studies and expert opinions rather than strong new evidence. This study aims to compare warfarin with clopidogrel-based antiplatelet therapy to find the optimal secondary prevention method for APS-related stroke. In this study, adult patients with confirmed APS and a history of ischemic stroke will be randomly assigned to one of two groups. One group will receive clopidogrel 75 mg daily and may also use other antiplatelet drugs if the doctor decides. The other group will be treated with warfarin, with a target blood clotting measure INR between 2.0 and 3.0. The study will follow participants for at least four years to assess outcomes. Participants will be monitored for any deaths, major cardiovascular problems, blood clots, and major bleeding events during the follow-up. The main outcome is a combined measurement of these serious events over four years. The study will provide important information to guide future treatment decisions for preventing strokes in APS patients. Throughout the study, safety and health will be closely observed by the researchers.

Researchers are evaluating the drug CMG190303 for treating adults with Type 2 Diabetes and Dyslipidemia. This phase III trial aims to compare how CMG190303 affects blood sugar control measured by HbA1c and cholesterol levels measured by LDL-C over 24 weeks, compared to two other treatments Rosuvastatin and Dapagliflozin. The study also monitors the safety of CMG190303 throughout the treatment period. Participants are randomly assigned to one of three groups those receiving CMG190303 a combination of Dapagliflozin and Rosuvastatin with doses increasing over 24 weeks, a group receiving Dapagliflozin with a Rosuvastatin placebo, or a group receiving Rosuvastatin with a Dapagliflozin placebo. The dosing schedule adjusts every 8 weeks with increasing amounts for both drugs in the CMG190303 group, while the placebo groups maintain consistent dosing. The trial is double-blinded, meaning neither participants nor researchers know which treatment is given. During the study, participants will have regular assessments to measure their HbA1c and LDL-C levels at various points up to 24 weeks. Additional blood tests will monitor fasting plasma glucose and other lipid parameters at 8, 16, and 24 weeks. Medication adherence is tracked, and safety monitoring is ongoing. The total participation duration is 24 weeks of treatment, during which researchers collect data to understand the drugs effects and safety in adults with these conditions.

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.

Researchers are evaluating the effectiveness and safety of the Synergy XD stent and Synergy Megatron122 Stent compared to other drug-eluting stents in patients with coronary artery disease. This study is a non-randomized, prospective, open-label registry designed to observe how these stents perform in real-world daily medical practice. The study aims to provide important information about outcomes such as death, heart attack, and the need for further vessel treatment. The study involves patients who receive percutaneous coronary intervention using either the Synergy XD stent or the Synergy Megatron122 stent. These devices are compared against other drug-eluting stents used in similar patients. Participants are followed over time with no random assignment to groups, allowing researchers to assess outcomes based on routine clinical care. Participants will be monitored through scheduled clinical follow-ups, with researchers tracking events including death, non-fatal myocardial infarction, and target vessel revascularization over one year. Additional outcomes such as cardiac death, stroke, stent thrombosis, and procedural success are assessed up to five years after treatment. The study collects data on patient safety and effectiveness of these stents during routine use, providing valuable long-term information on their clinical performance.

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.

Researchers are observing the long-term clinical outcomes of patients with unprotected left main coronary artery LMCA disease. This study aims to compare the results of three treatment approaches medical therapy, coronary stenting with drug-eluting stents DES, and coronary artery bypass grafting CABG in real-world daily practice. The study collects data from multiple centers across Korea and the Asia-Pacific region to better understand treatment effects in routine care settings. This multicenter registry will enroll approximately 5000 patients diagnosed with significant unprotected LMCA stenosis over 50% blockage by visual estimation. Participants will be followed prospectively to record their treatment courses and outcomes. The study does not assign treatments but observes patients undergoing medical therapy, PCI with DES, or CABG as decided by their doctors. Participants will be monitored for up to 10 years, with key outcomes including death, heart attacks, repeat vessel procedures, and cerebrovascular events. The primary outcome is a composite event rate measured at 2 years. Additional assessments include stent-related complications and rehospitalizations. Data collection will involve regular clinical follow-ups to capture these health events and understand the long-term effects of different treatment approaches.