Active clinical trials for "Cerebral Infarction"

The main objective of the study will be to investigate whether treatment with non-invasive vagus nerve stimulation (nVNS) on top of best medical practice in acute ischemic stroke patients results in less infarct growth in the penumbra and smaller infarct volumes compared with those of patients not treated with nVNS. The study will be a prospective randomized clinical trial with blinded outcome assessment (PROBE design). 150 patients will be randomized to nVNS with the gammaCore Sapphire™ device on top of best medical practice versus best medical practice alone (including intravenous thrombolysis and/or thrombectomy if indicated). If patients are randomized to nVNS, two stimulations of two minutes each will be applied in the neck every 15 minutes in the first 3 hours. Thereafter two stimulations will be applied every 8 hours over the next 5 days or until discharge, whichever occurs first. The stimulation side in the neck will be the radiological side of the stroke. The primary endpoint will be the final infarct volume on MRI scan on day 5 of patients treated with nVNS compared with those of patients not treated with VNS.

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo as tablets once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: Check vital signs such as blood pressure and heart rate Examine the participants' heart health using an electrocardiogram (ECG) Take blood samples Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia

This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) in combination with standard neurological complications after ischemic stroke treatment in Vietnam.

This prospective pilot study is intended to clarify whether the use of sodium valproate in patients with acute ischemic stroke can improve clinical outcomes, and to explore the mechanism: whether valproate could increase peripheral anti-inflammatory CD177+ neutrophils levels. Patients with acute ischemic stroke included in the study will be randomly assigned to low-dose sodium valproate group, high-dose sodium valproate group and placebo group. Besides receiving conventional treatment for stroke, 10mg/kg sodium valproate, 20mg/kg sodium valproate or normal saline were given intravenously for 3 consecutive days, respectively. The investigators evaluate whether sodium valproate can improve clinical outcomes and increase peripheral CD177+ neutrophil levels.

This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.

The bloodletting puncture is an external treatment for acute ischemic stroke by releasing an appropriate amount of blood with a three-edged needle at specific points on the patient's body. As a special treatment for acute ischemic stroke, it has been used clinically in hospitals of traditional Chinese medicine in China for many years and has achieved certain efficacy. However, there is a lack of comprehensive and objective clinical observation and mechanism research on this treatment method, as well as a lack of scientific efficacy evaluation standards and technical specifications. Therefore, we planned to explore the effectiveness, safety and accessibility of bloodletting puncture in the treatment of acute ischemic stroke through a mixed-method study of a multi-center randomised controlled trial and focus group.

A patient, suffering from cortical blindness after a bi-occipital infarction 1 year earlier, regained near-normal vision in the right visual hemifield a few minutes after subcutaneous administration of mepivacaine. The effect was maintained for several days, and was repeated with each injection of mepivacaine. This clinical improvement is associated with functional changes in the peri-lesional areas on resting-state functional MRI. The investigator team hypothesizes that in some patients with chronic neurological symptoms of stroke, the investigator team will observe a favorable response to subcutaneous mepivacaine injection.

English Synopsis I. Title of Study: A trial of BUN/Cr-based hydration therapy to reduce stroke-in-evolution and improve short-term functional outcomes for dehydrated patients with acute ischemic stroke-version 2. II. Indication: We use blood urea nitrogen (BUN)/blood creatinine (Cr) ratio≧15 as a dehydration biomarker. This clinical trial aims to determine if more aggressive intravenous fluid supplement instead of present treatment would yield a better outcome in patients with acute ischemic stroke and a BUN/Cr ratio≧15. III. Phase of Development: Phase III, randomized double-blind control trial. IV. Study Rationale: We have recently reported a novel finding that the blood urea nitrogen (BUN)/creatinine (Cr) ratio, a marker of hydration status, was an independent predictor of early neurological deterioration among patients who had suffered acute ischemic stroke. Pilot study was then designed to determine if providing hydration therapy, specifically intravenous saline infusion, to patients with a blood urea nitrogen/creatinine ratio (BUN/Cr) ≥15 improves outcomes after acute ischemic stroke. The results showed that patients with a presenting BUN/Cr ≥ 15 who received saline hydration therapy experienced a better functional outcome compared with similar patients who received standard therapy. V. Study Objectives: Primary objective: To compare the effectiveness of BUN/Cr-based hydration therapy with standard treatment in early neurological improvement (ENI) rate at 72 hours for dehydrated subjects with acute ischemic stroke Secondary objectives: To compare the benefit of BUN/Cr-based hydration therapy with standard treatment after three months using measure of modified Rankin scale (mRS) VI. Study Design: Duration of Treatment: 12 hours Number of Planned Patients: 288 subjects Investigational Product: normal saline Endpoints: Primary endpoint: To compare the ENI rate between group at 72 hours. ENI is defined as the improvement of the NIHSS score by 2 or more points or a score of 1 or 0 at 72 hours after the onset of stroke. Secondary endpoints: To compare the rate of favorable functional outcome at 3 months. Scores <=1 on the mRS are considered to indicate a favorable outcome. Criteria for Evaluation Inclusion criteria: Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist. has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS) the time between the onset of neurological symptoms and starting therapy are less than 24 hours admission BUN/Cr≧15 Exclusion criteria: no informed consent obtained initial NIHSS >10 prepared for or received fibrinolytic therapy prepared for or received surgical intervention with 14 days congestive heart failure according to past history or Framingham criteria history of liver cirrhosis or severe liver dysfunction (ALT or AST > x 3 upper normal limit) admission blood Cr >2 mg/dl initial blood pressure SBP<90 mmHg fever with core temperature >=38°C indication of diuretics for fluid overload any conditions needed more aggressive hydration or blood transfusion cancer under treatment life expectancy or any reasons for follow-up < 3 months Statistical Methods: The primary objective is efficacy using the binary endpoint of ENI. Descriptive statistics on continuous measurements will include means, medians, standard deviations, and ranges, while categorical data will be summarized using frequency counts and percentages. For the primary endpoint of ENI rate, the proportion of subjects with ENI response will be summarized by treatment group. The proportions of ENI will be compared between BUN/Cr-based hydration therapy (Arm A) and Standard therapy (Arm B) using two proportion Z test. The secondary objectives of this study are to evaluate the benefit of BUN/Cr-based hydration therapy after three months using measure of modified Rankin scale. For the secondary endpoint comparisons between groups, independent t-test will be considered. Duration of the Study: 3 years (or From 01/09/2020 to 31/08/2023) End of Study : When total 288 participants are enrolled or meet the criteria of early termination.

Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose. RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK therapies have a potential advantage of less systemic bleeding in treated subjects. Data from several previous studies suggest that rhPro-UK is efficacious when used to treat patients with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the National Medical Products Administration to treat acute myocardial infarction. Since then, rhPro-UK has been widely used to treat myocardial infarction in China. Since 2016, a phase 2 clinical trial was carried to explore the dosing of rhPro-UK in patients with acute ischemic stroke, followed by another study with a sample size of 680 patients to initially validate the efficacy and safety of the proposed dose of 35mg. The results of these studies suggested that rhPro-UK was effective, and there were no safety concerns. To further prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, investigators conducted this phase 3 study (PROST-2).