Acute Ischemic Stroke, Large Vessel Occlusion, Tenecteplase, Thrombolysis
Conditions
Brief summary
The goal of this clinical trial is to learn if tenectplase works to acute ischemic stroke (AIS) with onset 4.5-9 hours. It will also learn about the safety of tenectplase in AIS with onset 4.5-9 hours. The main question it aims to answer is: Does tenectplase improve the 90-days functional outcome in participants with acute large vessel occlusion? Researchers will compare tenectplase thrombolysis to non-use to see if tenectplase works to improve the functional outcome in participants with onset 4.5-9 hours. Participants will:\* Receive 0.25mg/kg (max 25mg) tenectplase at admission (after randomization) .\* Receive neurological assessment at admission, Day 5-7 or on hospital discharge (whichever earlier). Audio or video of the assessment may be recorded if possible.\* Receive brain CT + CT angiogram + CT perfusion and MRI after randomization, where the CT scan may be repetitive.
Interventions
DRUGTNK
a dose of 0.25 mg/kg (max 25 mg) administered as a bolus
DRUGStandard medical treatment
antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or greater * Acute ischemic stroke presenting in the 4.5 to 24 hour window from last seen well (including wake-up stroke and no witness stroke). * Prestroke mRS 0-2 * NIHSS 6 to 25 * Aspect ≥ 7 * ICA terminus, M1, dominant M2 occlusion on CTA or MRA * Clinical-imaging mismatch assessed by investigator * Patients with no access to EVT at the time of randomization
Exclusion criteria
* Current or past history of significant bleeding over the past 6 months; * History of intracranial hemorrhage (including possible subarachnoid hemorrhage or subarachnoid hemorrhage due to an aneurysm) or evidence or suspected intracranial hemorrhage; * Known bleeding tendency; * Recent severe or dangerous bleeding, or active ulcerative gastrointestinal disease; * History of central nervous system injury (e.g., intracranial tumor, aneurysm, or arteriovenous malformation, intracranial or spinal surgery), or recent head injury； * Tumors that increase risk of bleeding; * Severe liver dysfunction, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis; * Know arterial / venous malformation or aneurysm; * Bacterial endocarditis, pericarditis, or acute pancreatitis; * Patients receiving effective anticoagulant therapy (vitamin K antagonists with INR \> 1.3, or other oral anticoagulants exceeding the upper limit of the corresponding standard range); * Heparin use within the past 48 hours and prothrombin time exceeding the upper limit of the standard range; * Over the past 3 months, undergone major surgery, organ biopsy, or suffered a serious injury; * Over the past 2 weeks, receiving prolonged ( \>2 minutes) cardiopulmonary resuscitation, childbirth, or non-stressful vascular puncture (such as subclavian or jugular vein puncture); * Stroke episode occurred with epileptic seizure; * History of stroke comorbid with diabetes; * History of stroke over the past 3 months； * Acute bleeding tendency, including platelet count below 100×10⁹/L or other conditions; * SBP \>185 mmHg or DBP \>110 mmHg, or requiring intensive treatment (intravenous antihypertensive drugs) to lower blood pressure to within limits; * Blood glucose \<2.8 mmol/L or \>22.2 mmol/L (\<50 mg/dL or \>400 mg/dL)； * Patient life expectancy of less than 1 year; * Simultaneous occlusion of multiple blood vessels, defined as bilateral MCAs or MCAs combined with the basilar artery; * Pregnant women or nursing mothers； * Patients with a low likelihood of 3-month follow-up； * Over the past 3 months participated in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with functional independence outcome (mRS 0-2) at day 90 | 90 days after procedure | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ordinal shift of modified Rankin Scale | 90 days after procedure | The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death |
| Proportion of patients with functional independence outcome (mRS 0-1) at day 90 | 90 days after procedure | Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
| Recanalization of occlusion site according to the arterial occlusive lesion (AOL) scale | 24 hours after randomization | It specifically measures the mechanical success of recanalization at the site of the original occlusion.The scale ranges from 0 to 3, with higher scores indicating better recanalization. Grade 0: No recanalization (persistent occlusion). Grade 1: Incomplete recanalization (partial reopening with minimal flow). Grade 2: Partial recanalization (significant flow but residual stenosis or thrombus). Grade 3: Complete recanalization (full restoration of flow with no residual occlusion). |
| Change in Neurological Function of Participants Assessed by National Institute of Health Stroke Scale | Baseline and 7-days after randomization (or at discharge) | Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively. |
| Symptomatic intracranial hemorrhage (SICH) as defined by the Heidelberg Bleeding Classification | within 36 hours after randomization | SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 24 hours , or any hemorrhage leading to death. |
Countries
China
Contacts
Primary ContactWei Hu, MD, PhD
Outcome results
None listed