Tenecteplase vs Medical Management in 4.5-24h LVO no Access to EVT (TNK LATE)

University of Science and Technology of China (USTC)

Status and phase: Not yet enrolling; Phase 3

Conditions: Large Vessel Occlusion; Tenecteplase; Thrombolysis; Acute Ischemic Stroke

Treatments: Drug: Standard medical treatment; Drug: TNK

Study type: Interventional

Funder types: Other

Identifiers

NCT07168278

2025KY348

Details and patient eligibility

About

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.

Enrollment: 794 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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794 participants in 2 patient groups, including a placebo group

TNK

Experimental group

Description:

Participants will receive intravenous tenecteplase at a dose of 0.25 mg/kg (max 25 mg) administered as a bolus after enrollment. Subsequent treatment will be administered with antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Treatment:

Drug: TNK

Standard medical management

Placebo Comparator group

Description:

Participants will receive antiplatelet drugs, anticoagulation or combinations of these treatment modality according to national and institutional guidelines.

Treatment:

Drug: Standard medical treatment