Iksan

Researchers are evaluating the effectiveness of esketamine nasal spray for improving depressive symptoms in adults with treatment-resistant depression (TRD). The study focuses on participants diagnosed with major depressive disorder (MDD) who have not responded adequately to at least two previous oral antidepressant treatments during their current depressive episode. This Phase 4 study measures changes in depression severity using the Hamilton Depression Rating Scale over a 4-week treatment period. Participants will self-administer esketamine nasal spray at doses of either 56 mg or 84 mg into each nostril. The treatment phase lasts 28 days, during which participants receive the nasal spray under study conditions. The open-label, single-arm study takes place across multiple centers in Korea and aims to assess both the safety and effectiveness of esketamine in this population. During the study, participants will undergo assessments of depressive symptoms using the Hamilton Depression Rating Scale from baseline (Day 1) through Day 28. Safety and clinical status will be monitored throughout the treatment period. The primary outcome measure is the change in the total score on the Hamilton Depression Rating Scale from the start to the end of the 4-week treatment phase. Participants must meet specific eligibility criteria and are monitored closely to evaluate their response to the nasal spray treatment.

Researchers are comparing two methods for guiding complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention (PCI) using drug-eluting stents. The study evaluates anatomical guidance using quantitative coronary angiography (QCA) versus physiological guidance using fractional flow reserve (FFR) to determine which approach leads to better clinical outcomes. This open-label, randomized trial includes patients with symptomatic or ischemic evidence and coronary artery lesions suitable for PCI. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with diameter stenosis of 50% or more as measured by QCA, or the FFR-guided group, where PCI is performed on lesions with FFR values of 0.80 or less. Imaging guidance during PCI is left to the operator's discretion, with routine high-pressure post-dilation recommended to optimize stent expansion. Follow-up visits occur at 1, 6, and 12 months, with continued observation up to 5 years after the initial procedure. During the study, researchers will monitor and evaluate clinical outcomes such as death, myocardial infarction, and repeat unplanned revascularization within 12 months. Participants will undergo clinical assessments at scheduled follow-ups to track safety and effectiveness. The study aims to provide insights into the best guidance strategy for complete revascularization in patients with coronary artery disease treated with drug-eluting stents.

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 evaluating the drug CMG190303 for treating adults with Type 2 Diabetes and Dyslipidemia. This Phase III trial aims to compare changes in blood sugar control (HbA1c) and cholesterol levels (LDL-C) between CMG190303 and standard treatments Rosuvastatin and Dapagliflozin. The study also focuses on assessing the safety of CMG190303 in this patient population. Participants receive different drug combinations over a 24-week period. One group takes CMG190303, which combines Dapagliflozin and Rosuvastatin with doses increasing every 8 weeks. Another group receives Dapagliflozin with a Rosuvastatin placebo, and a third group receives Rosuvastatin with a Dapagliflozin placebo, with doses also increasing every 8 weeks. This design allows comparison of the investigational drug against standard therapies. Throughout the study, participants undergo assessments including blood tests to monitor HbA1c and LDL-C levels. Researchers track changes from the start of the study to 24 weeks to evaluate treatment effects. Safety is monitored continuously, and medication adherence is checked during run-in periods. The study includes adults aged 19 to 80 years with Type 2 Diabetes and Dyslipidemia, and total participation lasts at least 24 weeks.

This research aims to assess the effectiveness and safety of two specific stents, the Synergy XD stent and Synergy Megatron194 Stent, compared to other drug-eluting stents in patients with coronary artery disease. The study is a non-randomized, prospective, open-label registry designed to observe real-world daily practice outcomes in patients with various cardiovascular and heart diseases including myocardial ischemia and coronary disease. Participants will receive treatment through percutaneous coronary intervention using either the Synergy XD stent or the Synergy Megatron194 Stent. The study compares these devices against other drug-eluting stents. It is an observational study conducted across multiple centers without random assignment, focusing on routine clinical use of these stents. Throughout the study, researchers will monitor participants for the composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization over one year. Participants will undergo clinical follow-up evaluations according to the study protocol, with data collected on safety and effectiveness outcomes. Informed consent is required, and participant involvement includes scheduled clinical assessments and monitoring for cardiovascular events.

Researchers are evaluating whether adding an Implantable Cardioverter Defibrillator (ICD) to optimal medical therapy can reduce death from any cause in patients with variant angina who have experienced aborted sudden cardiac death. This phase 4 study focuses on patients who have had a successfully resuscitated cardiac arrest due to ventricular fibrillation or rapid ventricular tachycardia, with variant angina confirmed by coronary spasm and ST elevation or provocation tests. The goal is to compare outcomes between those receiving ICD plus medical therapy and those receiving medical therapy alone. Participants will be assigned to receive either an Implantable Cardioverter Defibrillator along with optimal medical therapy or optimal medical therapy alone. The ICD device is implanted to monitor and correct heart rhythm abnormalities. The study monitors patients for a total of five years, including a final assessment at the last subject's last visit to check for any endpoint events such as death. Throughout the five-year period, participants will be regularly monitored to assess survival and any related health events. Researchers will carefully track death from any cause as the primary outcome. This long-term follow-up allows for comprehensive evaluation of the impact of ICD implantation compared to medical therapy alone in this patient group.

Researchers are studying clinical outcomes of a new treatment approach for patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI). This Phase 4 trial evaluates stopping aspirin after PCI and using low-dose colchicine with ticagrelor alone. The study aims to measure the combined rate of cardiovascular death, heart attack, stroke, urgent heart procedures, and major bleeding, as well as stent thrombosis, all at 12 months after treatment. It also compares this approach to various durations of dual antiplatelet therapy from other trials to assess effectiveness. Participants will take low-dose colchicine (0.6 mg once daily) along with ticagrelor (90 mg twice daily) after PCI, stopping aspirin the day after the procedure. One month after PCI, participants will have a blood test for high-sensitivity C-reactive protein (hs-CRP). If the hs-CRP level is below 2 mg/L, colchicine will be stopped; if not, colchicine will continue for 12 months. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-PCI. During the study, participants will attend regular clinic visits for health check-ups and testing. Researchers will monitor clinical events, lab results, and overall safety throughout the 12-month period. The main outcomes measured are adverse clinical events and stent thrombosis at one year to assess both efficacy and safety of the colchicine and ticagrelor treatment combination after PCI in ACS patients.

Researchers are evaluating clinical outcomes of two different guidance methods for percutaneous coronary intervention (PCI) in patients experiencing acute myocardial infarction (AMI), including ST elevation myocardial infarction (STEMI). The study compares the use of optical coherence tomography (OCT), an intracoronary imaging technique, with traditional coronary angiography guidance. This research addresses the limitations of angiography alone, such as variability in lesion assessment and stent optimization, aiming to provide evidence on the long-term impact of OCT-guided PCI in this patient group. Participants will be assigned to one of two groups: the angiography-guided PCI group or the OCT-guided PCI group. In the angiography group, PCI is performed as standard with stent optimization based on angiographic findings, including criteria like residual diameter stenosis less than 10% and absence of flow-limiting dissections. When stent under-expansion is suspected, additional balloon dilatation is recommended. In the OCT-guided group, stent optimization includes detailed OCT criteria such as minimal lumen area thresholds for different lesions, no major malapposition of the stent, and absence of significant edge dissections. These procedures aim to optimize stent placement and improve vessel outcomes. During the study, participants are followed to assess clinical outcomes, including target vessel failure measured two years after the last patient enrollment. Researchers will monitor the participants' heart condition, stent performance, and any adverse events. Consent and understanding of risks and benefits are ensured before participation. The study includes patients undergoing primary PCI within 12 hours of symptom onset, with various safety and eligibility assessments conducted to ensure appropriate enrollment and compliance. The trial provides valuable data on the effectiveness and safety of OCT-guided versus angiography-guided PCI in AMI patients over an extended follow-up period.

Researchers are examining how different target levels of low-density lipoprotein (LDL) cholesterol affect patients who have had a small vessel occlusion (SVO) stroke, a type of ischemic stroke. The study addresses a gap in current stroke guidelines, which do not clearly define optimal LDL-cholesterol targets for different stroke types, especially for SVO stroke where hypertension is a major risk factor but high LDL-cholesterol may also contribute. This trial aims to improve secondary prevention by comparing intensive versus standard lipid-lowering therapies in adults with confirmed SVO stroke within 180 days of starting the study. Participants will be randomly assigned to one of two groups: an intensive treatment group targeting LDL-cholesterol levels under 70 mg/dL, or a standard treatment group targeting LDL levels between 90 and 110 mg/dL. Treatments include statins with or without ezetimibe, and if necessary, PCSK9 inhibitors to help achieve these LDL-cholesterol goals. The study plans to enroll 4,016 participants from multiple centers and will follow them for at least four years to monitor cardiovascular health outcomes. During the study, participants will have their LDL-cholesterol levels regularly checked and receive lipid-lowering therapies adjusted as needed to meet their target. Researchers will monitor major adverse cardiovascular events such as cardiovascular death, stroke recurrence, and acute coronary syndrome over the follow-up period. Participants must consent to the study and be available for long-term follow-up, which will provide important data to guide optimal cholesterol management for SVO stroke patients.

Researchers are comparing two common monitoring methods—the Stroke Volume Variation (SVV) from an arterial line and the Pleth Variability Index (PVI) from a pulse oximeter—to see which better predicts how the heart responds to small fluid infusions during laparoscopic major abdominal surgery. The study focuses on adults undergoing elective surgery under general anesthesia, aiming to improve goal-directed fluid therapy, which can vary due to changes during surgery like pneumoperitoneum and patient positioning. This prospective, single-center study enrolls about 300 adults to evaluate diagnostic accuracy using standardized fluid challenges.