Vsevolozhsk

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial to evaluate the efficacy and safety of Dimephosphon4 in patients with acute ischemic stroke. The study focuses on adults aged 35 to 80 who have experienced a hemispheric ischemic stroke confirmed by CT or MRI, with neurological symptoms scored between 5 and 15 on the NIH Stroke Scale. The goal is to understand how well Dimephosphon4 works and how safe it is compared to a placebo treatment. Participants are randomly assigned to one of two groups in equal numbers: one group receives Dimephosphon4, a 1 g/ml concentrate for intravenous infusion, while the other group receives a placebo IV solution. The study includes a screening period lasting up to 48 hours and a treatment period covering Visits 2 through 4. This design helps compare the effects of the drug to placebo on stroke recovery over a short timeframe. During the study, participants undergo several clinical assessments using standardized scales such as the NIH Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and EQ-5D quality of life questionnaire. The primary outcome is the percentage of subjects achieving favorable scores on the mRS at Day 15. Safety and treatment effects are carefully monitored throughout the visit schedule. Participants are followed closely to assess neurological function and recovery after treatment, with total participation lasting through the treatment visits.