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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a 24-week observational study to monitor the safety and effectiveness of the Enerzair inhalation capsule in adults with asthma under routine clinical care. This study is prospective, open-label, multicenter, and single-arm, designed to gather real-world data without altering standard treatment practices. The goal is to evaluate how Enerzair performs in everyday use over nearly six months. Participants in this study will be adults with asthma who have already been prescribed one of two doses of Enerzair inhalation capsules via Breezhaler, following approved labeling in Korea. The two dosages used are 150/50/80 micrograms and 150/50/160 micrograms. There is no treatment assignment by the study; instead, patients continuing their prescribed Enerzair treatment will be observed. No additional diagnostic tests or monitoring beyond routine clinical care will be performed. During the 24-week study, researchers will track any adverse events or serious adverse events, including unexpected ones, to assess safety. Participants will provide informed consent for data collection. The study will observe patients through their usual care visits, focusing on safety outcomes without additional interventions or procedures. This real-world surveillance helps understand Enerzair's tolerability and safety profile over six months in a broad adult asthma population.
Actively Recruiting
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.
Actively Recruiting
This research aims to evaluate the effectiveness and safety of the Ultimaster17 Tansei17 stent in patients with coronary artery disease during routine clinical practice. The study focuses on real-world daily use of this stent to better understand its outcomes in typical healthcare settings. Participants in this study will receive the Ultimaster17 Tansei17 stent as part of their treatment. The study is observational and takes place across multiple centers, with patients being monitored after receiving the stent. There are no comparison groups; the focus is on those treated with this specific stent. During the study, researchers will follow patients closely, assessing major outcomes such as death, nonfatal heart attacks, or the need for repeat procedures on the treated blood vessel within one year. Participants will have clinical follow-ups according to the study schedule, and safety and effectiveness data will be collected throughout this period to provide a comprehensive view of the stent's performance in everyday medical care.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of the DESyne X2, a novolimus-eluting stent, in routine clinical practice. The study focuses on adults aged 19 years and older who have coronary stenosis, coronary occlusion, or other coronary diseases. This multicenter, prospective observational study aims to collect real-world data about this specific stent device. Participants receive treatment using the DESyne X2 drug-eluting coronary stent. The study does not involve comparison groups but monitors patients who undergo intervention with this stent as part of their standard care. There is no maximum age limit defined, and the study observes outcomes following the stent placement. During the study, researchers will track the composite event rate over one year after the intervention. Participants will be monitored for safety and effectiveness outcomes through their routine clinical visits. The total participation duration includes at least one year of follow-up to assess the stent's performance and any related cardiac events.
Actively Recruiting
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.
Actively Recruiting
Researchers are studying the best timing for coronary angiography (CAG) in patients who have a type of heart attack called non-ST-segment elevation myocardial infarction (NSTEMI) complicated by acute decompensated heart failure (AHF). The trial aims to see if performing CAG immediately within 2 hours after diagnosing NSTEMI reduces the combined risk of death, another heart attack, or hospitalization for heart failure within 12 months, compared to delaying CAG until after the patient's condition stabilizes. Participants diagnosed with NSTEMI and AHF will be randomly assigned to one of two groups: one receiving immediate coronary angiography within 2 hours of diagnosis, and the other receiving delayed coronary angiography after their symptoms improve and lung congestion clears, sometime later during their hospital stay. This approach allows comparison of early versus delayed invasive treatment strategies in this high-risk patient group. During the study, participants will be monitored for major health events including death, non-fatal heart attacks, and hospitalizations for heart failure over a 12-month period. Researchers will track these outcomes to evaluate the safety and effectiveness of immediate versus delayed coronary angiography. The study also involves detailed assessments of heart failure symptoms and lung congestion to determine stabilization before delayed treatment.