Clinical Research Directory

Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke

This prospective observational cohort study examines whether blood pressure variability and nighttime blood pressure patterns, measured non-invasively over 72 hours with a cuffless ring-type wearable device, help predict recovery in patients with acute ischemic stroke. In acute ischemic stroke, how much blood pressure fluctuates - and whether it drops normally during sleep - may affect brain injury and outcome. Standard cuff monitors measure blood pressure only intermittently and can disturb sleep, which limits assessment of these patterns. This study uses a finger-worn cuffless continuous monitor to capture blood pressure without disturbing sleep. The study also examines whether the burden of pre-existing cerebral small vessel disease, seen as white matter changes on brain MRI, changes how strongly blood pressure variability relates to outcome. Blood pressure data are collected for research analysis only and are not used to guide treatment. All clinical care follows standard stroke guidelines, regardless of study participation. The main outcome is functional recovery (modified Rankin Scale) at hospital discharge.

Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: Impact on Inflammatory Biomarkers and Outcomes

This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of oral DLBS1033 as adjunctive therapy on inflammatory biomarkers (IL-6, TNF-α, MMP-9, D-dimer), transcranial Doppler (TCD) parameters, and clinical outcomes in patients with acute ischemic stroke. Fifty-two eligible patients admitted to RSUD Dr. Moewardi Surakarta will be randomly assigned to receive either DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) or placebo for 28 days, in addition to standard therapy between July 2024 to March 2025. The study was conducted in the inpatient ward, with follow-up at the outpatient clinic of the Neurology Department, Dr. Moewardi General Hospital, Surakarta, Central Java, following full ethical approval from the hospital's Health Research Ethics Committee. Primary outcomes include changes in inflammatory markers; secondary outcomes include changes in NIHSS and Barthel Index scores and TCD profiles.

Effect of Exercise Gene Expression and Histone Modifications in Patients With Hemiplegia

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.

Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset

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.

Benson Relaxation for Anxiety, Depression, and Insomnia After Stroke

Stroke is a leading cause of disability worldwide. Many patients experience anxiety, depression, and sleep disturbances in the early recovery phase, which can slow rehabilitation. Medications for mood symptoms may have side effects, especially in acute stroke patients. Benson Relaxation Technique (BRT) is a non-pharmacological mind-body intervention involving breathing exercises, muscle relaxation, and guided imagery.This multicenter, assessor-blinded, randomized controlled trial aims to evaluate the short-term effects of BRT on anxiety, depression, sleep quality, quality of life, and prefrontal brain function in patients 7-14 days after ischemic stroke. A total of 84 participants will be randomly assigned (1:1) to either the BRT group or a structured health education active control group. Interventions will be delivered twice daily for 20 minutes over 14 days.Outcomes will be assessed at baseline (T0) and post-intervention (T1, day 14). Assuming a 10-12% dropout rate, approximately 10 participants will withdraw, leaving 74 participants (37 per group) to complete the study and be included in the final analysis. The primary outcomes are the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include the Stroke-Specific Quality of Life Scale (SS-QOL) and resting-state functional near-infrared spectroscopy (fNIRS) metrics.

Intra-arterial Thrombolysis For Acute Ischemic Stroke With Medium Vessel Occlusion

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, distal M2 \[above the mid-insular height\], M3 or M4; A2, A3 or A4; or P2 or P3 segments, confirmed by CTA or MRA), compared with best medical management alone. Eligible participants (aged 18-80 years, baseline NIHSS score 6-25, confirmed MeVO within 24 hours of symptom onset or last known well) will be randomly assigned 1:1 to the intra-arterial thrombolysis plus best medical management group or the best medical management alone group. The primary endpoints are (i) the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 90±7 days post-randomization; (ii) the proportion of patients with symptomatic intracranial hemorrhage (sICH) within 48 hours post-randomization, defined and classified according to the Heidelberg Bleeding Classification; and (iii) the proportion of patients with early neurological deterioration (END) within 7 days post-randomization, defined as an increase of ≥ 4 points in the total NIHSS score from baseline or an increase of ≥ 2 points in any single NIHSS item. Secondary endpoints: 1. Procedure-related complications within 24 hours post-randomization; 2. Recanalization rate (meTICI ≥ 2b) at 24±12 hours post-randomization; 3. Any intracranial hemorrhage within 48 hours post-randomization; 4. Early neurological improvement (NIHSS score change from baseline) at 7 days or discharge; 5. Overall distribution of mRS scores at 90±7 days (shift analysis); 6. Excellent functional outcome (mRS score 0-1) at 90±7 days; 7. Functional independence (Barthel Index score 95 or 100) at 90±7 days; 8. Health-related quality of life (EQ-5D-5L) at 90±7 days; 9. All-cause mortality within 90±7 days.

CO2 Modulation in Endovascular Thrombectomy for Acute Ischemic Stroke

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.

Artificial Intelligence Support for Stroke

This study investigates whether an AI-assisted decision support tool, compared with standard care, increases the proportion of acute ischemic stroke patients receiving intravenous thrombolysis within 24 hours of symptom onset at a primary hospital in China, while also evaluating its impact on clinical outcomes, treatment timelines, and safety.

Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

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.

Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

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.

A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke

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.

MyStroke for Stroke Survivors and Caregivers

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.

Effects of Minocycline on Patients With Ischemic Stroke Undergoing Intravenous Thrombectomy

Minocycline is the second generation of tetracycline. Because of its lipophilicity, it has high penetrance of blood-brain barrier. Animal model studies have shown that minocycline can reduce cerebral damage after ischemic stroke, and its mechanism involves multiple molecular pathways, such as antioxidant, anti-inflammatory, anti apoptotic pathways, and protection of blood-brain barrier. Clinical studies have also shown that minocycline can significantly improve 3-month National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) of patients with ischemic stroke, indicating that minocycline is a potential neuroprotective drug. Minocycline is believed to protect the blood-brain barrier, thereby reducing the ischemia-reperfusion injury caused by mechanical thrombectomy. However, whether minocycline can become a synergistic treatment method of mechanical thrombectomy, there is no clinical research in this area at present. Therefore, investigators carry out the study on the effect of minocycline in patients with acute anterior circulation ischemic stroke after mechanical thrombectomy, and plan to enroll 180 patients. To explore the safety and effectiveness of minocycline in patients with acute ischemic stroke after thrombectomy.

TeleStroke-Guided Thrombolysis for Acute Ischemic Stroke in Oman

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.

Clinical Efficacy and Mechanism Research of Getong Tongluo Capsule in 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.

Tegoprazan for Prevention of Gastrointestinal Complication in Ischemic Stroke Patients on Antiplatelet Therapy (TegoStroke)

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.

Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial

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.

Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition

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.

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

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.

Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke

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.

A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy

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.

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Myocardial Injury Following Acute Ischemic Stroke

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.

Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke

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.

Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients

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.