Karlsbad

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and efficacy of intravenous thrombolysis IVT in adults who have experienced an acute ischemic stroke AIS and have taken direct oral anticoagulants DOAC within the last 48 hours. This international, multicenter, randomized trial compares IVT plus standard care to standard care alone in 906 participants to determine if IVT leads to better outcomes 90 days after treatment. Participants are randomly assigned to one of two groups one receives intravenous Tenecteplase or Alteplase along with the best medical treatment following local guidelines, while the other receives only the best medical treatment. The treatment is administered according to current recommendations from leading stroke organizations. The study aims to test whether IVT is superior in improving recovery in AIS patients with recent DOAC intake. During the study, participants are monitored and evaluated at multiple time points, including assessments of stroke severity, functional outcomes using the Modified Rankin Scale at 90 days, and quality of life questionnaires. Safety and efficacy are carefully tracked through these measures. Participants progress is followed up to about 90 days after randomization to assess the main outcomes and overall health status.