Status:
RECRUITING
Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
Lead Sponsor:
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aims to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 m...
Eligibility Criteria
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 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;
Key Trial Info
Start Date :
November 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
890 Patients enrolled
Trial Details
Trial ID
NCT07201688
Start Date
November 30 2025
End Date
September 30 2027
Last Update
December 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001