Cinisello Balsamo

Researchers are evaluating the impact of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerotic plaque burden in patients with Homozygous Familial Hypercholesterolemia HoFH, a rare genetic disorder marked by very high LDL cholesterol from early life and increased risk of early heart disease. This observational study includes both retrospective and prospective data, aiming to understand how Evinacumab affects plaque progression compared to conventional treatments. Participants are divided into two groups based on routine clinical care one receiving intensified therapy with Evinacumab added to stable lipid-lowering treatments, and the other receiving conventional lipid-lowering therapy without Evinacumab. Coronary computed tomography angiography CCTA scans, performed as part of routine care, will assess plaque volume and characteristics over 18-24 months. The study observes changes in non-calcified plaque volume, total plaque burden, high-risk plaque features, and LDL cholesterol levels. Participants will provide data from past and future routine clinical care, including CCTA imaging and laboratory tests. Patient-reported outcomes and adipose tissue characteristics around coronary arteries will also be evaluated. Researchers will track changes over time, focusing on plaque stability or regression, with safety information collected from medical records. The study is expected to last up to 24 months of follow-up with about 52 patients enrolled across multiple European centers.

Researchers are comparing two regional anesthesia methods to manage pain after elective total hip arthroplasty THA performed via the anterior approach. This randomized controlled trial evaluates the use of a Pericapsular Nerve Group PENG block combined either with a Lateral Femoral Cutaneous Nerve LFCN block or with wound infiltration WI to find which method better controls postoperative pain. The study focuses on pain intensity at rest six hours after surgery and also looks at other factors like opioid use and mobility. Participants will be randomly assigned to one of two groups. One group receives a PENG block with an LFCN block under ultrasound guidance, using 20 ml and 10 ml of 0.5% ropivacaine respectively, following neuraxial anesthesia. The other group receives a PENG block with 20 ml of 0.5% ropivacaine and a wound infiltration of 10 ml 0.5% ropivacaine after surgery. Both procedures are standard clinical practices with minimal additional risk. During the study, participants will be assessed for pain at rest and during movement at 6, 24, and 48 hours after regional anesthesia. Researchers will also measure opioid consumption, time to first rescue pain medication, muscle strength, hip flexion, length of hospital stay, and any complications. Safety is closely monitored throughout. Participation involves regular evaluations up to 48 hours post-surgery and observation of hospital stay length, with study activities concluding by November 2026.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.