Status:
NOT_YET_RECRUITING
Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT
Lead Sponsor:
The First Affiliated Hospital of University of Science and Technology of China
Conditions:
Acute Ischemic Stroke
Large Vessel Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
794 Patients enrolled
Trial Details
Trial ID
NCT07168278
Start Date
November 1 2025
End Date
May 31 2028
Last Update
September 11 2025
Active Locations (1)
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1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China