Clinical Trial News

OCT-guided PCI of complex coronary lesions is superior to angiography-guided PCI for CV outcomes at 1 year, with a 5% vs. 7% major adverse cardiac events rate. The trial compared OCT-guided (n = 803) vs. angiography-guided (n = 801) PCI in 1,604 patients, using everolimus-eluting stents. OCT guidance led to greater contrast use and longer procedure times but reduced ischemia-driven target lesion revascularization.

Elixir Medical's INFINITY-SWEDEHEART trial of DynamX Bioadaptor meets primary endpoint of target lesion failure (TLF) non-inferiority at 12 months, with low event rates despite complex patient population. Landmark analysis shows significant reduction in TLF and target vessel failure (TVF) after six months, confirming the unique mechanism of action.

Arrowhead Pharmaceuticals is preparing two RNAi-based drugs for obesity and metabolic diseases, aiming to start clinical trials early next year.

The SPEC-AI Nigeria trial evaluated AI-guided ECG-based screening vs. clinical ECGs alone for identifying cardiomyopathy among pregnant/postpartum women in Nigeria, utilizing AI algorithms for ECG analysis. The trial, funded by Mayo Clinic and NIH, involved six hospitals, with participants aged 18-49, randomized to AI-guided screening or standard ECG, followed up to 12 months postpartum. The primary outcome was identification of LVEF < 50% by echocardiography, with secondary outcomes including AI model performance and effectiveness in identifying various LVEF levels.

DR.NOAH BIOTECH received FDA approval for the IND application for a Phase 1 clinical trial of NDC-011, a new drug combination for ALS, developed using their AI platform ARK.

Pulmonary vein isolation significantly reduced atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life compared to a sham procedure, indicating no placebo effect.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an investigational therapy for generalized myasthenia gravis (gMG), based on data from the Phase III Vivacity-MG3 trial. Nipocalimab, an FcRn blocker, showed sustained disease control in gMG patients over 24 weeks, marking the longest controlled safety and efficacy assessment in this patient group.

IDMC recommended continuation of IO Biotech's Phase 3 trial of IO102-IO103 without modifications after a safety and efficacy interim analysis. No new safety signals were observed, and the primary endpoint of progression-free survival is projected to be reached in the first half of 2025.

Investigators explore alternative interventions like intubation, inferior turbinate fracture, or balloon dilation for CNLDO in older children, contrasting with age-based single procedure approach. A one-stage approach categorizes patients by obstruction type, requiring different interventions for simple vs. complex CNLDO. Clinical trial results show no significant change in success rate for simple CNLDO with added interventions in 12-24 months olds, but higher success with intubation in 24-36 months olds, suggesting treatment should consider patient age, surgical skills, instruments, and parental preferences.

Callum, diagnosed with acute myeloid leukaemia at age three, underwent intensive chemotherapy and participated in a Cancer Research UK-funded clinical trial. Now in remission, he enjoyed a magical trip to Lapland with his family, highlighting the importance of research in improving children's cancer survival rates.