Ischemic Stroke, Acute

LUMEN is a multicenter, randomized, double-blind, placebo-controlled superiority trial designed to evaluate whether oral lumbrokinase enteric-coated capsules combined with aspirin improve functional outcomes compared with aspirin alone in patients with moderate-to-severe acute ischemic stroke. Eligible adults aged 18-80 years with a baseline NIHSS score of 4-20, prestroke mRS ≤1, and onset within 24 hours are randomly assigned 1:1 to receive either lumbrokinase (600,000 IU, three times daily for 28 days) plus aspirin 100 mg daily for 90 days, or matching placebo plus aspirin 100 mg daily for 90 days. All participants receive standard medical care according to guidelines. The primary efficacy endpoint is the proportion of patients achieving an excellent functional outcome (modified Rankin Scale score 0-1) at 90 days. The primary safety endpoint is the incidence of severe or moderate bleeding (GUSTO definition) within 90 days.

Ischemic stroke accounts for the majority of stroke cases in China, and moderate ischemic stroke (NIHSS 4-10) carries a high risk of early neurologic deterioration (END) and long-term disability. Although intensified antiplatelet strategies reduce END, they have not consistently improved long-term functional outcome. Tirofiban, a selective glycoprotein IIb/IIIa receptor inhibitor, has shown a clinically meaningful trend toward better 90-day functional outcome (mRS 0-1) in prior tirofiban trials, but existing sample sizes were underpowered to detect this difference. TAMIS is a multicenter, randomized, double-blind, placebo-controlled superiority trial in patients with acute moderate ischemic stroke (NIHSS 4-10) within 24 hours of last known well. Eligible patients are randomized 1:1 to tirofiban plus aspirin versus placebo plus aspirin, both on a background of guideline-based standard medical care. The primary efficacy endpoint is the proportion of patients with an excellent functional outcome (mRS 0-1) at 90 days. The primary safety endpoint is symptomatic intracranial hemorrhage within 48 (±12) hours by the Heidelberg criteria.

The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.

The goal of this multicenter randomized trial is to evaluate the impact of a personalized video-based stroke education platform on patient-centered and health system-centered outcomes. The main questions this study aims to address are: 1. Does a personalized, video-based educational platform improve stroke knowledge? 2. Does a personalized, video-based educational platform reduce post-discharge health system utilization? 3. Do different strategies of nudging improve engagement with educational material after hospital discharge? In order to determine the effect of this personalized stroke education strategy, researchers will compare subjects who receive standard stroke education with those who receive the personalized stroke education platform in addition to standard standard education. Patient knowledge will be assessed 90-days after discharge. Study participants will include both stroke patients and caregivers, who will: 1. Receive standard education during the stroke hospitalization 2. Complete a survey on the day of hospital discharge to assess their baseline knowledge. 3. Half of the subjects will be randomly assigned to also receive access to the personalized stroke education platform on the day of discharge. 4. All subjects will complete two follow-up study visits (7 and 90 days after discharge) in order to complete surveys.

This study tests whether Benson Relaxation Technique (BRT), a simple mind-body relaxation method, can help reduce anxiety and depression in patients who had an ischemic stroke 7-14 days ago. Patients will be randomly assigned to either the BRT group (receiving 20-minute relaxation sessions twice daily for 2 weeks) or a control group (receiving health education sessions of the same duration). We will measure anxiety and depression using standard questionnaires, and use near-infrared brain imaging to see if BRT changes brain activity in the prefrontal cortex. The goal is to find a safe, non-drug way to improve mood in early stroke recovery.

Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial. At the clinical sites, patients with acute ischemic stroke within 4.5-24 hours of symptom onset will be randomized to receive a single bolus injection of the recombinant non-immunogenic staphylokinase (Fortelyzin®, LLC "SuperGene", Russia) or placebo.

The goal of this study is to establish and examine the efficacy of using a Telestroke network in Oman to facilitate using emergent thrombolysis for patients with acute ischemic stroke encountered in selected peripheral hospitals. It is proposed to establish a TeleStroke network involving two central hospitals in Muscat linked to three to five peripheral hospitals in Oman which currently have access to CT scans and basic infrastructure for management of AIS patients- but do not have a Neurology service. Selected staff from Internal Medicine/Emergency Medicine departments, Nursing, Technical service and support staffs will be trained in the process of assessment and management of AIS patients including the use of IV alteplase or tenecteplase. They will also be trained in timely access of a Neurologist on call at the central hospital(s) using a TeleStroke network. The Neurologist would conduct a Telestroke based clinical assessment of the AIS patient, review imaging and laboratory results in a timely manner and advice the medical team at the peripheral hospital regarding administration of IV alteplase/tenecteplase. The main purpose of such consultation would be to recognize eligible patients for administration of IV thrombolysis safely at the earliest opportunity within 4.5 hours, leading to increased rates of such thrombolysis with expected improved outcomes. Outcomes would be compared among 100 patients with AIS managed across these 5 hospitals prior to initiation of the practice of thrombolysis and at least 100 patients treated each with IV alteplase using TeleStroke Consultation with Neurologist. Demonstration of efficacy of TeleStroke based stroke thrombolysis would lead to effective implementation of this practice in Oman.

Patients with ischemic stroke commonly receive antiplatelet therapy, frequently starting as dual antiplatelet therapy, which is associated with an increased risk of gastrointestinal complications. Although evidence for gastroprotection is established in coronary artery disease, no comparable guidance or evidence exists for stroke care. Tegoprazan is a potassium-competitive acid blocker offering rapid, meal-independent acid suppression with fewer drug interactions than proton pump inhibitors, yet whether it prevents such complications after stroke remains unknown. Thus, the investigators aim to evaluate whether tegoprazan reduces gastrointestinal complications in patients receiving antiplatelet therapy after ischemic stroke. TegoStroke is a phase 3, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at more than 20 centers in the Republic of Korea. Adult patients who are starting antiplatelet therapy after acute ischemic stroke or transient ischemic attack, and who are expected to continue it for at least 6 months, will be included. Eligible patients will be 1:1 randomized to receive oral tegoprazan 50 mg once daily or matching placebo for 180 days. The primary outcome is a composite of upper or indeterminate-origin gastrointestinal bleeding, gastric or duodenal ulcer ≥3 mm, or erosive esophagitis, ascertained up to a day-180 esophagogastroduodenoscopy. This study would provide the first randomized evidence on routine gastroprotection for patients on antiplatelet therapy after ischemic stroke.

The purpose of this single-center, randomized, double-blind, controlled trial is to clarify the clinical efficacy and safety of Getong Tongluo Capsule in patients with ischemic stroke. Combined with gut microbiome and metabolomics techniques, investigators will explore whether this medicine exerts neuroprotective effects via the gut-brain axis. Investigators will further verify its pharmacological mechanism through animal experiments to provide evidence for its clinical application.

Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP \<130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[≥180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management.

Study purpose: A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) phase III trial is planned to evaluate the efficacy and safety of intra-arterial thrombolysis (IAT) in patients with acute ischemic stroke caused by medium vessel occlusion (MeVO), compared with best medical management alone. Eligible participants (aged 18-80 years, baseline NIHSS score 6-25 or 3-5 with disabling deficits, confirmed MeVO within 24 hours of symptom onset) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group. Primary endpoint: proportion of patients with favorable functional outcome (modified Rankin Scale score 0-2) at 90±7 days post-randomization. Secondary endpoints: 1. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization; 2. Early neurological improvement (NIHSS score change from baseline) at 7±1 days or discharge; 3. Overall distribution of mRS scores at 90±7 days (shift analysis); 4. Excellent functional outcome (mRS score 0-1) at 90±7 days; 5. Health-related quality of life (EQ-5D-5L) at 90±7 days; 6. Functional independence (Barthel Index score 95-100) at 90±7 days; 7. Symptomatic intracranial hemorrhage (sICH) per Heidelberg criteria within 48 hours; 8. Early neurological deterioration (NIHSS increase ≥ 4 points or any single item increase ≥ 2 points) within 7 days; 9. Any intracranial hemorrhage within 48 hours; 10. Procedure-related complications; 11. All-cause mortality within 90±7 days.

Most stroke patients are initially evaluated at the closest hospital but some need to be transferred to a hospital that can provide more advanced care. The "Door-In-Door-Out" (DIDO) process at the first hospital can take time making transferred patients no longer able to get the advanced treatments. This study will help hospitals across the US "stand up" new ways to evaluate stroke patients, decide who needs to be transferred, and transfer them quickly for advanced treatment.

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

We will investigate the therapeutic efficacy of EEG-synchronized noninvasive repetitive transcranial magnetic stimulation (rTMS) in the early subacute phase after ischemic stroke to improve upper limb motor rehabilitation. We hypothesize that synchronization of rTMS with the phase of the ongoing sensorimotor oscillation indicating high corticospinal excitability leads to significantly stronger improvement of paretic upper limb motor function than the same rTMS protocol non-synchronized to the ongoing sensorimotor oscillation or sham stimulation.

This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Investigators will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.

Introduction: The management of acute myocardial injury following acute ischemic stroke (AMI-AIS), a frequent complication that severely worsens prognosis, is challenging. Remote ischemic conditioning (RIC) has demonstrated therapeutic potential in separate cardiac and cerebrovascular diseases, and preliminary single-center evidence suggests its safety and efficacy in patients with acute ischemic stroke (AIS) complicating acute myocardial infarction. Therefore, we propose to conduct a multicenter, randomized controlled trial to definitively evaluate the safety and efficacy of RIC in patients with AMI-AIS. Methods: This is a multicenter, randomized, double-blind, sham-controlled trial of 580 participants with AMI-AIS. Participants will be randomized to receive either the RIC procedures or sham RIC procedures twice daily for 14 consecutive days. A 3-month follow-up will be conducted to assess the safety and efficacy of RIC in AMI-AIS patients. The primary study outcome is the incidence of major adverse cardio-cerebrovascular events (MACCEs). The secondary outcomes include mortality, neurological and cardiac function, cerebral infarct volume, and cerebral perfusion.

This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.

The aim of this study is to demonstrate the effect of routine exercise program on neuroplasticity through histone acetylation and gene expression changes in acute stroke survivors from an epigenetic perspective and to investigate the correlation of epigenetic effects with its effects on motor function and quality of life.

This prospective cohort study investigates predictors of post-stroke cognitive impairment (PSCI) in patients undergoing endovascular thrombectomy (EVT) for acute ischemic stroke due to large vessel occlusion. Adult patients with successful reperfusion (mTICI 2b-3) will be followed at 3 and 6 months to assess cognition, functional recovery, and depression. Predictors across clinical, procedural, radiological, and laboratory domains will be analyzed. The study aims to identify risk factors for PSCI, estimate its prevalence, and evaluate its impact on outcomes.

Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.

This clinical study investigates Expansion-floating Craniotomy (EC), a novel surgical technique for treating life-threatening malignant cerebral edema following large hemispheric infarction (commonly known as massive stroke). Malignant edema causes rapid increases in intracranial pressure, compressing vital brain structures and risking fatal brain herniation, requiring urgent intervention. The current international standard treatment is traditional decompressive craniectomy (DC). DC involves removing a section of the skull to allow brain swelling, effectively reducing pressure and mortality risk. It is strongly recommended (Class I, Level A evidence) in major guidelines. However, DC typically requires a second major surgery (cranioplasty) approximately 3 months later to replace the removed bone flap, involving additional costs and risks like progressive intracranial hemorrhage or subdural hygroma. EC is a newer approach designed to potentially eliminate the need for a second surgery. During EC, surgeons use medical titanium plates to temporarily elevate the bone flap, creating immediate space for brain swelling while keeping the bone flap attached. Once brain swelling subsides (usually within weeks), a minor procedure flattens the titanium plates, allowing the patient's own bone to naturally reposition without requiring cranioplasty. EC may be performed based on surgeon assessment of brain swelling, guideline considerations, or experience. If EC is deemed unsuitable during surgery, DC will be performed instead. While early research suggests EC achieves decompression similar to DC while preserving the bone flap, its safety and effectiveness compared to the established DC procedure are not yet fully proven. DC is a well-understood, mature technique with known risks and benefits, including the certainty of needing cranioplasty. Conservative management is reserved for patients unfit for surgery but may not prevent neurological deterioration.This study aims to conduct a preliminary assessment of the outcomes of EC versus DC.

It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigators hypothesize that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone in patients with evidence of a large infarct volume. The primary objective of the study is to establish the efficacy of methylprednisolone with EVT in patients with acute anterior circulation LVO and a large infarct core.

This study is intended to assess the incidence and correlation to the development of peri-device leaks (PDLs), device related thrombosis (DRTs) and cerebral vascular accident (CVA)/transient ischemic attacks (TIAs) in association with left atrial appendage contrast flow (LAA-CF). It will be a multi-center, retrospective study. Approximately 100 subject charts will be reviewed.

A phase I/IIa clinical trial investigating the safety and preliminary efficacy of intravenous administration of human induced neural stem cell-derived exosomes for acute ischemic stroke

There is a lack of complex studies which could establish the association between genetic circadian factors with the features and short-term outcomes of ischemic stroke, as well as the effects of various auxiliary therapies for circadian rhythm modulation for neuroplasticity enhancement and improvement of short-term outcomes in ischemic stroke. The main research hypothesis is that circadian factors influence the recovery from ischemic stroke via sleep-mediated regulation of synaptic plasticity. The project aims at the investigation of the influence of combined melatonin therapy and blue light exposure on molecular circadian biomarkers, sleep characteristics, neuroplasticity markers and stroke outcome in acute stroke patients. This study is a prospective, interventional, randomized placebo-controlled trial.