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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating clinical outcomes for patients who begin inclisiran treatment within about two weeks after experiencing a heart attack STEMI or non-STEMI. This observational study focuses on patients in Russia and aims to understand the effects of inclisiran on lipid profiles, safety, atherosclerotic plaque status using carotid ultrasound, and the rates of hospitalizations and intensive follow-up over a 12-month period. Participants receive their first inclisiran injection approximately 14 days after their heart attack. The study observes changes in lipid levels at baseline, 3, 9, and 12 months, as well as plaque progression or regression over the year. Researchers also monitor adverse events, therapy discontinuation, hospital readmissions, emergency care visits, and the timing of dispensary observation. During the 12 months of participation, patients undergo lipid profile testing, carotid ultrasound scans, and safety evaluations at specified intervals. The main measure is the number of patients experiencing atherosclerotic cardiovascular disease events within a year after starting inclisiran in addition to their usual therapy. Secondary assessments include LDL cholesterol levels, plaque changes, adverse events, rehospitalizations, and use of emergency services, all tracked to evaluate the therapys impact and safety in real-world settings.
Actively Recruiting
Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.