Clinical Research Directory

Real-World Evaluation of Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours

Acute ischemic stroke is a major cause of disability and death. Intravenous thrombolytic therapy is an important treatment option when given within the appropriate time window. Recombinant human prourokinase (rhPro-UK) is a thrombolytic medication approved for the treatment of acute ischemic stroke within 4.5 hours after symptom onset in China. This prospective, multicenter cohort registry study aims to evaluate the effectiveness and safety of intravenous rhPro-UK in patients with acute ischemic stroke treated within 4.5 hours of symptom onset. Approximately 3,000 patients from multiple centers will be enrolled and followed for 90 days. Clinical outcomes, bleeding events, adverse events, and functional recovery will be collected and analyzed to provide further evidence on the use of rhPro-UK in routine clinical practice.

The Effect of GD-iExo-003 in Acute Ischemic Stroke

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. The objective of this study is evaluating safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cell (GD-iExo-003) in acute ischemic stroke.

Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)

This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies.

OPtimizing REperfusion by Primary Intra-Arterial ThRomboLysis for Medium Vessel Occlusion

PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of primary intra-arterial thrombolysis in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.

Safety and Efficacy of J147 in Acute Ischemic Stroke

The goal of this clinical trial is to find out if the drug J147 improves outcomes for persons who have had an ischemic stroke. It also will learn about the safety of J147 when given by injection to stroke patients. Researchers will compare the outcomes of those who receive J147 after therapy to clear the blood clot to those who don't receive J147. Participants will be asked to undergo a series of three to four magnetic resonance imaging (MRI) brain scans, and blood samples will be collected at several time points. Participants will also be evaluated to measure several aspects of brain function.

Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke

The HOPE-MeVO study aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke due to medium vessel occlusion presenting 4.5 to 24 hours after stroke onset or last known well. Eligible patients will be selected based on CT perfusion imaging and randomly assigned to receive rhPro-UK plus standard medical treatment or standard medical treatment alone. The primary objective is to determine whether rhPro-UK improves functional outcome at 90 days.

A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well

This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot. The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke. Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment. Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT). * Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.

Efficacy and Safety of Home-based Structured Physical Exercise in Patients With Acute Ischemic Stroke

This study is a randomized controlled, open-label, blinded endpoint trial. The investigators aim to assess the efficacy and safety of home-based structured physical exercise in participants with acute ischemic stroke.

Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring

This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2

This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.

A Study of TAK-755 in Adults With Acute Ischemic Stroke

Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible. The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking. The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

A Study of B2065 in Patients With Acute Ischemic Stroke

The goal of this clinical trial is to evaluate the safety of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection. It will also assess whether B2065 works to treat acute ischemic stroke. The main questions it aims to answer are: At what dose range is the drug safe for participants? Which dose shows preliminary efficacy? Researchers will compare B2065 to a placebo (a look-alike substance that contains no drug) to see if B2065 works to treat acute ischemic stroke. Participants will: Receive a single dose of B2065 during hospitalization Visit the hospital as scheduled for safety and efficacy assessments

Intra-arterial Selective Hypothermic Magnesium Sulfate Infusion in Combination With Endovascular Thrombectomy in Acute Ischemic Stroke

The primary objective of this study is to estimate the safety and effectiveness of selective intra-arterial hypothermic magnesium sulfate infusion after endovascular thrombectomy in patients with acute ischemic stroke. Addendum regarding phase 1 dosing implementation and planned phase 2 design: This integrated phase 1/2 trial originally planned weight-individualized magnesium perfusate calculated as Target Mg (μmol/mL) = 0.6 × patient body weight. During phase 1 recruitment, no dedicated emergency pharmacy fast-track compound workflow existed for urgent EVT procedures, which would cause reperfusion delay if individualized mixing was performed intraoperatively. Therefore, a uniform fixed magnesium concentration of 20.29 mmol/L was adopted as a temporary operational solution for all 9 phase 1 participants, with dose escalation only performed by increasing total infusion volume (350/500/650 mL). For the upcoming phase 2 cohort, we will retain the fully safe 650 mL maximum infusion volume and conduct independent magnesium concentration escalation across six ascending tiers: 20.29, 22.54, 25.36, 28.98, 33.81, and 40.57 mmol/L. These concentrations are prepared by diluting the standard 5 g magnesium stock into 1000 mL, 900 mL, 800 mL, 700 mL, 600 mL, and 500 mL pre-cooled normal saline respectively. After defining the maximum tolerated magnesium concentration tier, the original weight-tailored compounding formula will be fully implemented for subsequent efficacy cohorts. All protocol adjustments have received institutional review board amendment approval.

Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy

Acute ischemic stroke caused by blockage of a large brain artery can lead to severe disability. Endovascular thrombectomy is a catheter-based procedure used to remove the blood clot and restore blood flow. It can benefit selected patients treated 6 to 24 hours after stroke onset, but some patients remain disabled even when the blocked artery is successfully reopened. Ongoing injury to brain tissue, small blood vessels, and the blood-brain barrier may contribute to this incomplete recovery. This multicenter randomized clinical trial will evaluate whether Cerebrolysin, given after successful extended-window endovascular thrombectomy, can reduce brain tissue injury and support recovery. The study will enroll 100 adults aged 18 to 80 years at three stroke centers in Taiwan. Participants will be randomly assigned, after successful reperfusion has been confirmed, to receive either Cerebrolysin 30 mL or a matched normal saline placebo by intravenous infusion once daily for 10 consecutive days. The first infusion will begin within 36 hours of stroke onset. All participants will also receive standard stroke care and rehabilitation. The primary outcome is final infarct volume measured by diffusion-weighted magnetic resonance imaging on Day 7 to Day 10. Other outcomes include functional recovery at 3 and 12 months, neurological improvement, symptomatic intracranial hemorrhage, cerebral edema, recurrent stroke, mortality, cognition, language, and mood. The study will also examine blood-brain barrier injury using computed tomography perfusion, dynamic contrast-enhanced magnetic resonance imaging, and serial plasma Claudin-5 measurements. This study will determine whether Cerebrolysin shows evidence of reducing postreperfusion brain injury after successful thrombectomy and will help guide the design of a larger trial focused on clinical outcomes.

A Phase II Clinical Study of LT3001 for Injection in the Treatment of Acute Ischemic Stroke

This phase II clinical study is designed to evaluate the efficacy and safety of LT3001 in the treatment of acute ischemic stroke

Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events

Acute ischemic stroke caused by large vessel occlusion (LVO) is a major cause of disability, and mechanical thrombectomy (MT) has become the standard treatment for eligible patients. However, the optimal role of intravenous thrombolysis before MT remains uncertain. The TRACE-BRIDGE trial is a phase 3, investigator-initiated, multicenter, randomized, open-label trial with blinded outcome assessment (PROBE design) evaluating different bridging thrombolysis strategies before MT. The trial will enroll adults with acute ischemic stroke presenting within 4.5 hours of symptom onset and with imaging-confirmed anterior circulation LVO who are eligible for intravenous thrombolysis and MT. Participants will be randomly assigned in a 1:1:1 ratio to receive tenecteplase plus MT, reteplase plus MT, or direct MT alone. The TRACE-BRIDGE trial aims to evaluate the efficacy and safety of bridging thrombolysis with tenecteplase or reteplase before mechanical thrombectomy compared with direct mechanical thrombectomy. The primary outcome is functional independence, defined as a modified Rankin Scale score of 0-2 at 90 days after randomization. If superiority of bridging thrombolysis is demonstrated, the trial will further evaluate whether reteplase is non-inferior to tenecteplase as a bridging thrombolytic strategy.

Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy

To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.

A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke

The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). This study consists of 2 cohorts, Cohort A and Cohort B. Cohort A (redasemtide or placebo) will enroll participants who are ineligible for systemic thrombolysis and/or mechanical recanalization therapy. Cohort B (redasemtide or placebo) will enroll participants who are eligible to receive or who have received systemic thrombolysis and/or mechanical recanalization therapy as standard of care.

Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)

The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.

REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)

Post-Market Registry

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults

NTS-104 TRIS will be administered as a single intravenous dose to healthy subjects at doses of 0.8, 4, 8 and 16 mg/kg in 4 Cohorts. Each cohort of 8 subjects will begin with dosing 2 sentinel subjects with one being given the investigational product and one the placebo. If no safety issues arise, dosing the remaining subjects in the cohort will begin. A Safety Review Committee will review the safety and pharmacokinetic data before approving escalation to the next dose level.

Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy

1. The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment 2. The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment? 3. Participants will: receive HBO (1.6 Atmosphere Absolute，1.6ATA)，Once a day, for 1 hour each time, for 5 days a week (it can be non-consecutive days), the total course of treatment is 10 times. undergo three scheduled face to face or telephone follow-up assessments during the 12-month period following HBO.

Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)

The aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.