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New treatment option for Acute Ischemic Stroke
Official title Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
ClinicalTrials.gov ID: NCT07201688
What this study is testing
What is rhTNK-tPA?
rhTNK-tPA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Severe and persistent hypertension uncontrolled by medication ;
- Blood glucose \ 22.2 mmol/L;
See the full eligibility criteria
- 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...
- 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...
- Voluntary signing of the informed consent form by the participant or their legal guardian.
- 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...
- Severe and persistent hypertension uncontrolled by medication ;
- Blood glucose \ 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;
The study team makes the final eligibility decision.
Where it's taking place
- Puyang, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Puyang, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.