Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the effectiveness of nucresiran compared to a placebo in reducing death from any cause and cardiovascular events in patients with transthyretin amyloidosis that affects the heart. The study also aims to assess how nucresiran impacts additional cardiovascular events, mortality, and patient-reported health status and quality of life. This is a Phase 3, global, randomized, double-blind, placebo-controlled trial focusing on this serious heart condition. Participants will receive either nucresiran 300 mg or a placebo (sterile normal saline) via subcutaneous injection every six months. The study treatment period is expected to last about 32 months, with a maximum duration of up to 5 years. Both groups will be monitored closely throughout this time, and patients may continue other approved therapies for transthyretin amyloidosis and heart failure as recommended by their doctors. During the study, participants will undergo regular assessments to track all-cause mortality and recurrent cardiovascular events, including hospitalizations and urgent visits for heart failure. Other evaluations will include patient-reported health outcomes and quality of life measurements. Researchers will monitor safety and treatment effects over the full study period, with a focus on how well nucresiran may improve health and reduce cardiovascular complications in this patient population.