NCT07201688RecruitingPhase 3
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).
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 890 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- 30 Nov 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
- Diseases
- Stroke
- NCT number
- NCT07201688
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 890
- From 30 Nov 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Lab values
- Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L;
- Known platelet function defect or platelet count less than 100×10⁹/L;
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Puyang Oilfield General Hospital Coordinator of this site? Confirm its status | Puyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.