Rotenburg An Der Fulda

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 effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Atrial fibrillation is the most common heart rhythm disorder, increasing the risk of blood clots forming in the heart, especially in the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have had an intracranial bleed bleeding in the brain are often treated with blood thinners to prevent stroke, but these medications can increase bleeding risk. This study compares two treatment methods to prevent strokes in such patients blood thinners and a device that closes off the left atrial appendage of the heart. The study randomly assigns participants to one of two groups. One group receives a device called Watchman or Watchman FLX to close the left atrial appendage through a minimally invasive procedure, followed by short-term blood thinning medication. The other group receives standard oral blood thinners as per current guidelines. Only approved drugs and devices are used. The trial aims to provide data to help doctors manage patients with atrial fibrillation who have experienced brain bleeds. Participants are followed for up to three years after randomization. Researchers monitor for events such as death from cardiovascular causes, stroke, systemic embolism, and bleeding episodes. Assessments include imaging during the procedure and regular follow-up visits to track health outcomes. The main measure is event-free survival without these complications. This long-term follow-up helps evaluate the safety and effectiveness of each treatment approach in preventing strokes and bleeding.

Researchers are evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other lesion preparation methods like cutting or super high pressure balloon angioplasty and ablative procedures. The study focuses on treatment of severely calcified coronary artery stenoses in patients with coronary artery disease. It is a randomized, double-blind trial sponsored by Deutsches Herzzentrum Muenchen. Participants receive lesion preparation either by intravascular lithotripsy using balloons with a rated burst pressure of up to 18 atm or by other standard methods such as high, super high, cutting balloons, and ablative techniques. These procedures are performed before intracoronary stenting. The trial compares these approaches to assess additional benefits in treating severely calcified coronary lesions. During the study, participants are monitored for major cardiac and cerebrovascular events over 12 months after randomization. Researchers also track mortality, myocardial infarction, stroke, need for vessel revascularization, stent thrombosis, hospitalization for acute coronary syndrome, and bleeding events. Symptom assessments for physical and mental health related to coronary heart disease and medical costs are also evaluated. Safety and procedural success are closely observed throughout the study period.