Lubin

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with locally advanced, unresectable, or metastatic stomach or gastroesophageal junction (GEJ) cancer. This study focuses on cancer cells that are HER2-negative but positive for the Claudin 18.2 protein and PD-L1, exploring how well zolbetuximab helps the immune system attack the tumor alongside immunotherapy and chemotherapy. The trial is a phase 3, randomized, double-blind study designed to compare the overall survival of participants receiving zolbetuximab with pembrolizumab and chemotherapy versus those receiving a placebo with pembrolizumab and chemotherapy. Participants receive study treatment in 6-week cycles, with zolbetuximab or placebo given by infusion every 2 or 3 weeks. Chemotherapy regimens include either CAPOX (capecitabine tablets and oxaliplatin infusion) or mFOLFOX6 (infusions of 5-fluorouracil, folinic acid, and oxaliplatin) administered on schedules matching the cycles. Pembrolizumab is infused every 3 or 6 weeks. Treatment continues until cancer worsens, is not tolerated, or another therapy is needed, with pembrolizumab given for up to 2 years. After initial cycles, some chemotherapy drugs are adjusted to only include oral capecitabine or certain infusions. During the study, participants visit the clinic for treatments, health checks, and scans to monitor cancer changes and side effects. Researchers also track medical problems related to the treatments and may collect tumor samples if cancer worsens. After stopping treatment, participants have follow-up visits and scans every 9 to 12 weeks, along with telephone check-ins every 3 months. The primary outcome measured is overall survival up to 72 months, with ongoing monitoring to evaluate safety and treatment effects.

Researchers are evaluating the effects of three different dosing schedules of povorcitinib on lung function in adults with moderately to severely uncontrolled asthma. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess both the safety and efficacy of povorcitinib in improving respiratory outcomes for this patient group. Participants have a history of asthma treatment with medium- to high-dose ICS-LABA therapy and meet specific lung function criteria before enrollment. Participants will receive one of three povorcitinib dosing regimens or a placebo while continuing their background ICS-LABA therapy. The study includes multiple treatment arms to compare the effects of different doses. The intervention period lasts 24 weeks, during which pulmonary function and other health measures will be monitored. During the study, participants will undergo regular assessments, including lung function tests measuring pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) at baseline and week 24. Researchers will also monitor safety and collect data on asthma exacerbations and symptom control. The total participation time covers the treatment duration and follow-up evaluations to assess changes in pulmonary function and overall health status.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are conducting a prospective, multicenter, international clinical study to evaluate treatments for patients with bifurcation coronary artery disease, specifically those with certain Medina classifications and vessel diameters greater than 2.0 mm. The study includes patients requiring percutaneous coronary intervention (PCI) for stable coronary artery disease or acute coronary syndrome. The purpose is to compare the use of paclitaxel drug-coated balloons (SCB), sirolimus drug-coated balloons (PCB), and standard treatment with new generation drug-eluting stents (DES) for these bifurcation lesions. Patients will be randomly assigned in equal groups to receive one of the three treatments after successful predilatation of the lesion using any suitable tool. The PCI procedure will follow standard international guidelines and local practices. For those assigned to SCB or PCB, lesion preparation is mandatory before applying the drug-coated balloon. The study is open-label and randomized to ensure an unbiased assessment of these interventions. Participants will undergo follow-up assessments including 6-9 month evaluations of coronary artery function using CT-FFR or invasive FFR, focusing on stenosis severity in both main and side branches of the treated vessels. Throughout the study, patients will be monitored for clinical outcomes and safety. Enrollment requires informed consent and meeting specific eligibility criteria. The study aims to gather data on the effectiveness and safety of these treatment options over the study period.

Researchers are evaluating the outcomes of a heart procedure called bifurcation PCI (percutaneous coronary intervention) using two different techniques: Culotte and Double Kiss (DK) Culotte. The study looks back at patient data collected from two high-volume cardiac centers in the Lower Silesia Region of Poland between April 2012 and January 2024. This analysis focuses on patients with coronary artery disease who had bifurcation lesions treated with two stents implanted using one of these two techniques. The treatment involves implanting two coronary stents using either the Culotte technique or the DK Culotte technique. The choice of which technique to use was made by the operator based on clinical and angiographic features. The decision to perform this two-stent approach was guided by the Heart Team's judgment or specific clinical indications such as ongoing ischemia or significant coronary artery disease suitable for PCI. All patients provided informed consent after being told about treatment options and associated risks. Participants’ data were reviewed to assess target lesion failure, which is the primary outcome measured over a five-year period after the initial hospitalization. Follow-up evaluations occur every six months after the hospitalization ends, continuing until the five-year mark. The study excludes patients who had previous PCI with coronary stents for the bifurcation lesion being studied. This retrospective analysis helps compare the safety and effectiveness of these two stenting methods in treating bifurcation lesions.

Researchers are evaluating the long-term safety and effectiveness of Coronary Sinus Reducer implantation in patients with chronic disabling refractory angina pectoris who continue to have symptoms despite receiving the highest tolerated doses of anti-angina medications. This single-center, single-arm registry includes patients classified as Canadian Cardiovascular Society (CCS) classes 2 to 4 who were deemed unsuitable for other revascularization procedures by a specialized Heart Team. Participants receive the Coronary Sinus Reducer, a balloon-expandable, hourglass-shaped device implanted percutaneously into the coronary sinus via the venous system. This device creates a narrowing in the coronary sinus to delay blood outflow. After implantation, patients are followed with clinical assessments starting one month post-procedure, then every six months, continuing up to five years. During the study, participants undergo evaluations including a review of medical history, CCS angina class assessment, Seattle Angina Questionnaire (SAQ-7), six-minute walk test, and echocardiography before implantation. The main outcome measured is the reduction of angina symptoms one year after device placement. Safety and efficacy are monitored long-term through regular follow-ups over five years to track clinical success and device impact.

Researchers are evaluating the safety and effectiveness of using the Orbital Atherectomy Device during percutaneous coronary intervention (PCI) in patients with moderately to severely calcified coronary artery lesions. This observational registry study takes place at two cardiac centers in Poland and includes patients who have a clinical need for PCI based on current European Society of Cardiology guidelines. Eligible patients have calcification confirmed by angiographic imaging or intravascular methods like ultrasound or optical coherence tomography. The study involves PCI procedures facilitated by the Orbital Atherectomy Device to treat calcified coronary lesions. The decision to use this device is made by the operating cardiologist based on clinical and imaging assessments. All patients receive detailed information about treatment options and risks and provide written consent before participation. The study collects data on all consecutive cases where this treatment is applied. Participants are monitored up to 10 days after the procedure to assess clinical success and to record any treatment-emergent adverse events. Researchers review patient outcomes at discharge, focusing on procedural results and safety. Data collection occurs in two specialized cardiac centers, and the study aims to gather real-world evidence about the device's use in managing calcified coronary artery disease.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction (MI), including both ST-segment elevation MI (STEMI) and non-ST-segment elevation MI (NSTEMI), who also have multivessel coronary artery disease (CAD). The trial compares physiology-guided revascularization, which uses specific measurements to decide treatment, with angiography-guided revascularization, which relies on imaging. The study aims to determine if the physiology-guided approach is not worse than the angiography-guided method in preventing cardiovascular death, new MI, or ischemia-driven revascularization, and whether it is better at reducing safety issues like bleeding, stroke, or kidney injury. Participants undergo procedures to treat non-culprit lesions (NCLs) using either physiology guidance or angiography guidance. In the physiology-guided group, percutaneous coronary intervention (PCI) is performed on lesions with resting full-cycle ratio (RFR) of 0.89 or less or fractional flow reserve (FFR) of 0.80 or less, according to local practice. The angiography-guided group receives PCI based on imaging assessments following local practice. The study includes an observational imaging sub-study using optical coherence tomography (OCT) for a subset of patients. Participants are involved for a minimum of two years, during which researchers monitor the time to first cardiovascular events such as death, new MI, or additional revascularization, along with safety events like bleeding or stroke. The study includes regular evaluations and follow-up to assess these outcomes, ensuring comprehensive safety and efficacy data collection in this patient population.

This research aims to evaluate the safety, effectiveness, and clinical results of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in routine clinical practice in Poland. It focuses on rates of procedural success, complications, different PCI strategies and techniques, and the impact of artificial intelligence-based analysis on predicting outcomes and quality of life. The study includes a variety of patient subgroups, including those at higher risk due to conditions like low ejection fraction or diabetes. Patients receiving CTO PCI as part of their usual medical care will be enrolled in a national, multicenter registry. The study will observe different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It will also assess the use of intravascular imaging and mechanical circulatory support during PCI, examining how these factors relate to clinical outcomes. Participants will have clinical, procedural, and follow-up data collected to assess real-world results. Researchers will monitor procedural success within one day and track complications and cardiac injury markers after treatment. The study will analyze quality-of-life improvements and outcomes in high-risk groups over time, providing a comprehensive view of CTO PCI in contemporary practice.