Citta Di Castello

Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of LAquila. The study has two parts ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.