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Found 5 Actively Recruiting clinical trials

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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.

Age: 18Years +All GendersPhase 3
1264 locations
C

Actively Recruiting

Atrial fibrillation (AF) is a common heart rhythm disorder that can lead to serious complications like stroke and bleeding. Asian patients with AF tend to have higher rates of major bleeding, including bleeding in the brain, compared to non-Asian patients. This research focuses on understanding the use of blood-thinning medications called anticoagulants, especially newer drugs known as non-vitamin K antagonist oral anticoagulants (NOACs), which are considered safer than warfarin but are less commonly used in Asian countries due to cost concerns. The study aims to track changes in how these medications are used and how they affect health outcomes over time. The study is a large, prospective observational registry conducted across 33 centers in Thailand, enrolling 3680 patients with non-valvular AF over two years. There is no intervention or treatment assigned by the study; instead, researchers observe patients' current treatments and outcomes. Participants will be followed every six months for a total of three years to monitor their use of warfarin and NOACs and record any serious events such as stroke, systemic embolism, major bleeding, heart attacks, heart failure, and overall quality of life. Throughout the study, patients will undergo regular assessments including clinical evaluations and monitoring of their medication use. The main outcomes measured over the three years include rates of using warfarin and NOACs, occurrence of ischemic stroke or transient ischemic attack, systemic embolism, intracranial hemorrhage, and major bleeding events. This long-term follow-up aims to provide valuable information on treatment patterns and safety in Asian patients with atrial fibrillation.

Age: 18Years - 100YearsAll Genders
33 locations
E

Actively Recruiting

Researchers are evaluating whether starting norepinephrine early with rapid dose changes improves outcomes for adults with septic shock. The trial focuses on reducing death within 28 days, faster control of shock, and lowering fluid needs without increasing side effects. It compares early norepinephrine with standard care that uses placebo and rescue norepinephrine if needed. Participants receive norepinephrine started within one hour of septic shock diagnosis at 0.05 mcg/kg/min, adjusted every 15 minutes up to a maximum of 0.15 mcg/kg/min, or a matching placebo with the same dosing schedule. Both groups can get rescue norepinephrine if required. Limb ischemia and vital signs are closely monitored every 15 minutes during the 24-hour treatment period. During the study, participants undergo frequent assessments of blood pressure, limb perfusion, and safety monitoring. They receive standard sepsis treatments such as fluids, antibiotics, and organ support as needed. Researchers follow participants for up to 28 days to measure survival and any adverse effects related to the treatments.

Age: 18Years +All GendersPhase Not Applicable
6 locations
P

Actively Recruiting

Researchers are evaluating the effectiveness and safety of osimertinib tablets combined with Datopotamab Deruxtecan (Dato-DXd) intravenous infusion compared to osimertinib alone as a first treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Ex19del and/or L858R). This global Phase III, open-label, randomized study focuses on participants who have not received prior therapy for advanced disease. The goal is to show that the combination therapy improves progression-free survival compared to osimertinib alone. Participants will be randomly assigned to receive either osimertinib 80 mg orally once daily or osimertinib plus Dato-DXd at 6 mg/kg given by intravenous infusion every three weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or other reasons require stopping. Visits for assessments will occur every three weeks during treatment. For those on osimertinib alone or who discontinued Dato-DXd but continue osimertinib, visits will be every six weeks from cycle 7 to cycle 17, then every 12 weeks until disease progression or treatment stops. Participants receiving both drugs will have visits every three weeks. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their condition and treatment effects. Researchers will track progression-free survival through independent review about three years after the first participant is enrolled. The study is expected to last about eight years, with ongoing monitoring of safety and treatment tolerance throughout. Participants must attend scheduled visits for evaluations and treatment administration as outlined in the study plan.

Age: 18Years +All GendersPhase 3
166 locations
S

Actively Recruiting

Researchers are evaluating the safety and effectiveness of Volrustomig in women with high-risk locally advanced cervical cancer (stages IIIA to IVA) who have not experienced disease progression after completing platinum-based concurrent chemoradiation therapy (CCRT). This phase III, randomized, double-blind, placebo-controlled global study aims to provide new insights for this patient group by comparing Volrustomig to a placebo treatment. Participants will be randomly assigned in equal numbers to receive either Volrustomig or a placebo, both given through intravenous infusion. The study is conducted across multiple centers worldwide, maintaining a double-blind design to ensure unbiased results. Treatment details include administration of the investigational drug or placebo after completion of their initial CCRT. During the study, participants will be monitored for progression-free survival based on assessments by investigators, with follow-up lasting up to about seven years. Researchers will evaluate health status, organ function, and any side effects through regular clinical assessments and laboratory tests. Safety and long-term outcomes will be closely tracked to understand the impact of Volrustomig in this setting.

Age: 15Years +FEMALEPhase 3
204 locations
Amphoe Mueang Udon Thani Clinical Trials | DecenTrialz