Isleworth

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.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Researchers are evaluating the safety of two minimally invasive treatments for men with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). The study compares the iTind device, a temporary nitinol implant that reshapes the prostate over 5 to 7 days, with the UroLift system, which permanently places implants to widen the urethra. This post-market, international study aims to directly compare these options in men aged 50 and older with BPH symptoms requiring treatment. Participants will receive either the iTind device, which stays implanted for 5 to 7 days to reshape the prostatic urethra through pressure and tissue remodeling, or the UroLift procedure, which places permanent implants to retract enlarged prostate lobes. The study involves randomization and follows participants after treatment to assess safety and effectiveness. During the study, men will attend scheduled visits to complete questionnaires and undergo tests such as prostate imaging and urinary flow measurements. Researchers will monitor complications occurring during and after the procedures for up to 3 months. Participants must be able to complete all visits and assessments to help evaluate the treatments' safety profiles and effects on urinary symptoms.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

Aortic stenosis (AS) affects a significant portion of the elderly population, with approximately 5% of those over 65 years old and around 3% of those over 75 years having moderate to severe AS. The number of people with AS is increasing rapidly due to an aging population, creating challenges for clinicians in managing mostly elderly patients who are often symptom-free but have severe AS diagnosed incidentally. While symptomatic severe AS requires aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), the best approach for asymptomatic patients remains unclear. This trial aims to compare early AVR or TAVI with standard expectant management in these patients to provide evidence on clinical outcomes and cost-effectiveness. The study is a large, multi-center randomized controlled trial conducted in the UK, Australia, and New Zealand, with plans to expand internationally. It includes two phases: a vanguard phase and a main phase, with an internal pilot to ensure adequate recruitment over two years. Eligible participants with severe asymptomatic AS will be randomly assigned to either early AVR or ongoing surveillance (expectant management). Those in the early AVR group will undergo surgery within about three months, which may include additional procedures like coronary angiography and possible coronary interventions if needed. The trial uses intention-to-treat analysis to compare outcomes between groups. Participants will be closely monitored throughout the study, with evaluations including routine tests and assessments as part of their care. The primary outcome measured is a combination of cardiovascular death and hospitalization for heart failure over a minimum of three years. The study also collaborates with another trial, EVoLVeD, offering participants additional research opportunities. Overall, the study seeks to provide important data on whether early valve replacement before symptoms develop can improve outcomes for people with severe asymptomatic AS.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.