RecruitingPhase 3NCT07201688

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

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule) in Intravenous Thrombolysis for Acute Ischemic Stroke With Extended Time Window (4.5-24 Hours After Onset).

Sponsor

CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

Enrollment

890 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

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

Min Age: 18 Years

Inclusion Criteria6

Aged ≥ 18 years, regardless of gender;
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";
Modified Rankin Scale (mRS) score ≤ 1 before stroke onset;
Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
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);
Voluntary signing of the informed consent form by the participant or their legal guardian.

Exclusion Criteria9

Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA);
Patients with an expected life expectancy of less than 1 year;
Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator;
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;
Severe and persistent hypertension uncontrolled by medication ;
Blood glucose < 2.8 mmol/L or > 22.2 mmol/L;
Active internal bleeding with a high risk of hemorrhage;
Any known coagulation disorder;
Known platelet function defect or platelet count less than 100×10⁹/L;

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Interventions

DRUGrhTNK-tPA

Each vial should be dissolved in 3mL of sterile water for injection to prepare a drug solution with a concentration of 5.33mg/mL. Calculate the total drug amount based on the participant's actual body weight, measure the required volume of the drug solution, and ensure the maximum dose does not exceed 25mg. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.

DRUGPlacebo

One vial is dissolved in 3mL of sterile water for injection. Calculate the total drug amount based on the participant's actual body weight, then measure the required volume of the drug solution. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.