Tests rhTNK-tPA against placebo for stroke treated up to 24 hours later
Tests rhTNK-tPA against placebo in adults with large-vessel acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
Key facts
- Where
- Puyang, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a stroke caused by a blocked large brain artery who can be treated 4.5 to 24 hours after symptoms began. It tests the clot-dissolving drug rhTNK-tPA against placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke with a blocked internal carotid artery or middle cerebral artery (M1 or M2) seen on scan. Symptoms started 4.5 to 24 hours before treatment, wake-up strokes and unwitnessed strokes included. NIHSS score of 6 or more. Brain scan must show salvageable tissue (ischemic core under 70 mL, mismatch ratio at least 1.8, mismatch volume at least 15 mL).
Main reasons for not taking part
- Known allergy to rhTNK-tPA
- Life expectancy under 1 year
- Symptoms improving rapidly
- Severe high blood pressure not controlled by medicine
- Active internal bleeding, a known clotting disorder or platelet count under 100×10⁹/L
Read by machine on 12 November 2026.
Where in China
- Puyang Oilfield General HospitalPuyang, ChinaContact: Yutie Zhao, Chief PhysicianTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
- Trial code
- NCT07201688
- Record updated
- 16 December 2025
- Original description
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.Read full original descriptionShow less
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).
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.
Inclusion: 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: Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA); 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 ; Active internal bleeding with a high risk of hemorrhage; Any known coagulation disorder; Blood glucose < 2.8 mmol/L or > 22.2 mmol/L; Known platelet function defect or platelet count less than 100×10⁹/L; 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.