Actively Recruiting
Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
Led by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. · Updated on 2025-12-16
890
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Stroke symptom onset to treatment time between 4.5 and 24 hours, including wake-up or unwitnessed strokes
- Modified Rankin Scale score of 0 or 1 before stroke onset
- National Institutes of Health Stroke Scale score of 6 or higher at baseline
- Brain imaging confirming occlusion in specific brain arteries and target mismatch criteria
- Signed informed consent by participant or legal guardian
You will not qualify if you...
- Known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA)
- Life expectancy less than 1 year
- Rapidly improving stroke symptoms
- Severe consciousness impairment or seizures at stroke onset
- Severe uncontrolled hypertension
- Blood glucose below 2.8 mmol/L or above 22.2 mmol/L
- Active internal bleeding with high bleeding risk
- Known blood clotting disorders
- Platelet function defects or low platelet count below 100 x 10^9/L
AI-Screening
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Trial Site Locations
Total: 1 location
1
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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