Rivoli

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 ziltivekimab, a new medicine not yet approved anywhere, to see if it can reduce plaque buildup in the hearts blood vessels in people who have had a heart attack. The study focuses on patients with acute myocardial infarction and compares the effects of ziltivekimab against a placebo. This phase 3 trial aims to understand the impact of ziltivekimab on heart vessel plaque over about 15 months. Participants will be randomly assigned to receive either ziltivekimab or a placebo, both given as monthly injections under the skin for 12 months alongside standard heart care. The study uses advanced imaging techniques like intravascular ultrasound, near-infrared spectroscopy, and optical coherence tomography to monitor changes in the arteries. The treatment is administered shortly after participants undergo certain heart procedures. During the study, participants will undergo detailed heart imaging and blood tests at the start, at 4 weeks, and at 52 weeks to measure changes in plaque volume and inflammation markers. Researchers will monitor heart-related events like heart attacks, strokes, and deaths throughout the year. The study includes adherence tracking and safety monitoring to evaluate the treatments effects and any risks over the full duration.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the adherence, persistence, and effectiveness of PCSK9 inhibitors in treating hypercholesterolemia among a real-life Italian population. This observational study focuses on patients receiving these medications to better understand treatment patterns and outcomes outside of controlled clinical trials. Participants in this study are patients with hyperlipidemia who are currently treated with PCSK9 inhibitors, specifically Repatha evolocumab or Praluent alirocumab, administered by injection. The study observes these patients without altering their treatment, collecting data over time to assess how well patients stick to their treatment plans and how effective the medications are. During the study, researchers will gather information every six months about treatment adherence, persistence, and efficacy. They will also monitor safety and analyze results within different patient subgroups. Participation includes regular assessments of medication use and health outcomes, with the study continuing until March 31, 2030.

This research aims to develop, study, and validate a reliable method to assess whether hospital admission decisions made in the Emergency Department are appropriate. The study focuses on patients presenting with non-specific symptoms related to the lungs, heart, or abdomen, such as shortness of breath, chest pain, fainting, or abdominal pain. By evaluating these decisions, the study seeks to improve the quality of care in emergency settings. The study uses information routinely recorded in Emergency Department medical records along with clinical and administrative databases. It includes all patients aged 18 and over who arrive at participating centers between January 1, 2023, and December 31, 2024. The study will validate and refine a classification algorithm through several phases from August 2025 to June 2027, ultimately applying the algorithm to eligible patients to assess the appropriateness of hospital discharges. Participants data will be analyzed using computerized hospital databases without the need for extra interventions. Researchers will monitor and refine the algorithms performance over time, including qualitative and quantitative validation phases. The study spans from initial data collection through algorithm application and feasibility assessment, lasting until June 2027, with no direct treatment or follow-up required from participants during this observational process.

This research aims to develop a system for continuously evaluating healthcare quality in semi-intensive care units. By collecting patient data and hospital structure information, the study will identify indicators of unsuccessful care tailored to different patient types. These indicators will help assess the overall quality of care in each semi-intensive care unit over time. The study will last for five years, from 2021 to 2025, during which data from patients admitted to semi-intensive care units will be gathered. Annually, a detailed report will be produced to analyze and compare the results from each unit, helping to track improvements or identify areas needing attention. Participants include all patients hospitalized in participating semi-intensive care units, with an expected total of at least 39,000 patients over the study period. Researchers will monitor outcomes for various patient risk groups to assess healthcare quality. The study involves ongoing data collection and yearly evaluations to support continuous quality improvement in these care units.

Researchers are evaluating the use of intracoronary optical coherence tomography OCT guidance compared to angiography-only guidance during percutaneous coronary intervention PCI to treat coronary in-stent restenosis ISR. ISR remains a challenge despite advances in drug-eluting stents, and this trial aims to understand whether OCT can improve acute PCI outcomes by providing more detailed imaging guidance. The study is a randomized, multicenter, non-blinded trial including patients with acute coronary syndrome or stable ischemic heart disease who have ISR requiring PCI. Participants will be randomly assigned to one of two groups PCI guided by OCT plus angiography or PCI guided by angiography alone. In the OCT group, operators perform at least one OCT imaging run before and after PCI and may perform additional OCT runs during the procedure. In the angiography-only group, operators perform PCI guided by angiography, but OCT imaging is also done before and after PCI without the operator seeing the results to allow outcome comparison. Operators use standard PCI tools and techniques at their discretion in both groups. During the study, participants undergo diagnostic angiography followed by PCI with assigned imaging guidance. Researchers will assess the cross-sectional area of the treated coronary segment before and after PCI using imaging techniques. Additional data collected include the number of PCI maneuvers, intracoronary devices used, and quantitative flow ratio values. Participants will be followed for one year to monitor major adverse cardiovascular events. The total participation period includes the PCI procedure and follow-up evaluations up to one year post-procedure.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.