Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Acute Ischemic StrokeCerebral StrokeExtensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.
Safety and Efficacy of Evolocumab in Ischemic Stroke
Ischemic StrokeAcuteThe goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).
Multidimensional Evaluation of Patients With Acute Ischemic Stroke Undergoing Pharmacological and...
StrokeEndovascular Thrombectomy1 moreIn developed countries, stroke is the third leading cause of death and the leading cause of permanent disability. Systemic and endovascular thrombolytic treatments in acute cerebral ischemic stroke caused by occlusion of large caliber vessels are currently the standard of care for the acute treatment of stroke. The rationale of this study is to validate the results of this treatment on a large scale, in the context of what can be called "real life". The study will have the characteristics of a descriptive observational study on patients suffering from acute ischemic stroke treated at the Policlinico A. Gemelli-IRCCS from 1 January 2016 to 31 December 2023. These data will be compared with a retrospective control group of patients undergoing mechanical thrombectomy for cerebral ischemic stroke in our polyclinic. The primary endpoint is the outcome of patients treated with mechanical endovascular thrombectomy evaluated with the modified Ranking Scale at 90 days, while as secondary endpoints some individual characteristics of the patient will be considered (sex, age, clinical history, etc.), characteristics of the thrombus (anatomical-pathological, radiological etc) and related to acute management (therapy, rehabilitation, etc).
Correlation Between Brain Structure and Activity and Spontaneous Recovery of Motor Function Following...
Ischemic StrokeThe investigator aims to find a correlation between brain structure and activity and spontaneous recovery of motor function following brain ischemic stroke by Analysis of MRI scans. The research includes stroke patients and healthy patients (control group).
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke
Acute Ischemic StrokeLarge Vessel Occlusion2 moreA Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke
Acute Ischemic StrokeThis study is a multicenter, prospective, cohort study to observe the clinical efficacy and safety of edaravone dextrol in patients with acute ischemic stroke in a real-world setting.
Clinical Significance of DKK2 Protein in Cerebral Ischemia-reperfusion Injury
Ischemic StrokeAcute2 moreThe study is a two-center prospective cohort clinical trial. The primary purpose of this trial is to identify the pattern of DKK2 serum levels in ischemic stroke patients after revascularization therapy and determine the correlation between serum DKK2 levels and prognosis.
Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke
Ischemic StrokeThe purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.
Early Neurological Deterioration in Recent Small Subcortical Infarction
Cerebral InfarctionSubcortical Infarction3 moreRecent small subcortical infarction (RSSI) is defined as a small deep infarction in the territory of a perforating artery with maximum axial diameters (MAD) of less than 20 mm. Although RSSI is generally considered to be of a relatively favorable prognosis, about 13.5% to 43% of RSSI patients experience early neurological deterioration (END) in the acute phase, which often bring adverse effects on long-term outcomes. Although a number of risk factors for END have been identified previously, however, the risk factors of END and the underlying etiological mechanism are still ambiguous, and also the relevant intervention measures lack sufficient evidences, which is a thorny problem that clinicians have to face. In this multicenter, large-sample prospective registry study, we ought to investigate the natural course of END in patients with RSSI. Exploring the risk factors and potential mechanism of its occurrence and development, and trying to establish a comprehensive predictive model for END that integrates multi-dimensional information including clinical symptom, demographic data, biochemical biomarker and image data, and so as to provide a valuable tool for clinical evaluation and early management. Simultaneously, our study will provide information for the design of therapeutic randomized controlled trials in the future.
Minocycline Efficacy in Improving Neurological Outcome of Patients Who Undergo Endovascular Revascularization...
Acute Ischemic StrokeThe study will be a prospective, randomized, double- blinded placebo, single center pilot clinical trial. Patients with acute ischemic stroke due to large vessel occlusion undergoing endovascular thrombectomy will be included. The treatment group will receive 200 mg intravenous/oral minocycline hydrochloride in addition to endovascular thrombectomy for a total of 21 days. The control group will receive standard medical and endovascular care along with a similar looking placebo. Patients will be randomized to the treatment or control group by the Pharmacy eliminating the selection bias. The patient and evaluator will be blind to the allocation of patients further minimizing the bias. Through randomization we expect to achieve two groups that are comparable in their baseline clinical characteristics.