NCT07201688 Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 890 participants in total. It began in 2025-11-30 with a primary completion date of 2027-09-30.

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study plans to enroll patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset (including wake-up strokes and strokes without witnesses). A centralized 1:1 randomization will be adopted, and eligible participants will be randomly assigned to two groups: the experimental group will receive rhTNK-tPA at a dose of 0.25 mg/kg, while the placebo group will receive rhTNK-tPA placebo.

Eligibility Criteria

Inclusion Criteria: 1. Aged ≥ 18 years, regardless of gender; 2. Time from symptom onset to treatment is 4.5 - 24 hours(Including the boundary values.), including patients with wake-up stroke or stroke without witnesses; the time of symptom onset is defined as the "last known normal time"; 3. Modified Rankin Scale (mRS) score ≤ 1 before stroke onset; 4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6; 5. Neuroimaging findings: occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA) confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) + magnetic resonance perfusion (MRP) (ischemic core volume \< 70 mL, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 mL); 6. Voluntary signing of the informed consent form by the participant or their legal guardian. Exclusion Criteria: 1. Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA); 2. Patients with an expected life expectancy of less than 1 year; 3. Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator; 4. Patients with a score of \> 2 on Item 1a (Level of Consciousness) of the National Institutes of Health Stroke Scale (NIHSS), or those who had a seizure at stroke onset, or had hemiplegia after seizure, or had other neurological/psychiatric disorders that rendered them unable or unwilling to cooperate; 5. Severe and persistent hypertension uncontrolled by medication ; 6. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L; 7. Active internal bleeding with a high risk of hemorrhage; 8. Any known coagulation disorder; 9. Known platelet function defect or platelet count less than 100×10⁹/L;

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