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Found 6 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the efficacy and safety of autologous Mesenchymal Stem Cells MSC injected into the hepatic artery for patients with alcoholic liver cirrhosis. This phase III clinical trial aims to assess the effects of a single dose of Cellgram-LC on patients with this condition, focusing on outcomes up to 60 months after treatment. The study is sponsored by Pharmicell Co., Ltd. and involves patients diagnosed with alcoholic cirrhosis who meet specific clinical criteria. Participants are randomly assigned to one of two groups one receiving best supportive care without intervention, and the other receiving a single injection of 7x107 autologous bone marrow-derived mesenchymal stem cells Cellgram-LC delivered directly into the liver through the hepatic artery. The injection is performed within one month after bone marrow extraction. This open-label study monitors patients over several years to evaluate long-term outcomes. During the trial, participants undergo various assessments including survival evaluations, liver function tests, fibrosis measurements, and quality of life questionnaires at multiple time points up to 36 months. Researchers monitor transplant-free survival as the primary outcome over three years. Secondary outcomes include changes in liver severity scores, liver enzyme levels, fibrosis indicators, and health status measures. Safety and efficacy are evaluated throughout the study period, which extends up to five years from treatment.
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
This research aims to evaluate the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received the treatment in the PMC-P-07 clinical trial. The study focuses on monitoring safety outcomes over a 60-month period following a single dose of Cellgram-LC to understand its effects over time. Participants include those with alcoholic liver cirrhosis who had been administered Cellgram-LC in the earlier PMC-P-07 study. This follow-up study does not involve new treatments but observes the long-term safety of the previously given Cellgram-LC dose. During the 5-year follow-up, researchers will assess the rate of adverse events of special interest and the rate of liver transplants among participants. The study involves regular monitoring for up to 60 months to gather safety data and observe participants health outcomes related to their previous Cellgram-LC treatment.
Actively Recruiting
Researchers are investigating the best low-density lipoprotein LDL cholesterol targets for patients who have had a small vessel occlusion SVO stroke, a type of ischemic stroke affecting small blood vessels in the brain. This study addresses the gap in knowledge about optimal LDL-cholesterol levels for SVO stroke patients, as most previous trials focused on other stroke types. The goal is to improve secondary prevention strategies and patient outcomes by comparing intensive versus standard lipid-lowering therapies. Participants will be randomly assigned to one of two groups an intensive treatment group aiming for LDL-cholesterol levels below 70 mgdL, and a standard treatment group targeting levels between 90 and 110 mgdL. Treatments include statins with or without ezetimibe, and if needed, PCSK9 inhibitors to reach the LDL targets. The trial is open-label with blinded endpoint evaluation and plans to enroll over 4,000 adults who had an SVO stroke within the past 180 days. Throughout the study, participants will be followed for at least four years to monitor major cardiovascular events, including cardiovascular death, stroke, and acute coronary syndrome. Researchers will assess outcomes such as any stroke, ischemic stroke or transient ischemic attack, myocardial infarction, and overall death. This long-term follow-up will help determine the most effective LDL-cholesterol management for secondary prevention in SVO stroke patients.