rhTNK-tPA for large-vessel ischemic stroke treated 4.5–24 hours after last seen normal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase III trial comparing a single IV dose of rhTNK-tPA (0.25 mg/kg, max 25 mg) to placebo in adults with acute large-vessel occlusive ischemic stroke presenting 4.5–24 hours after last known normal, including wake-up strokes. Eligible patients must have ICA or M1/M2 MCA occlusion on CTA/MRA and a target perfusion mismatch on CTP or MR perfusion (core < 70 mL, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 mL), with baseline NIHSS ≥ 6 and premorbid mRS ≤ 1. Participants are centrally randomized 1:1 and the trial planned enrollment was 890 patients with a possible increase to 1,300 after an unblinded interim sample-size re-estimation. The primary goal is to compare clinical outcomes between rhTNK-tPA and placebo in this extended treatment window.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years, regardless of gender;
2. 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";
3. Modified Rankin Scale (mRS) score ≤ 1 before stroke onset;
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
5. 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);
6. Voluntary signing of the informed consent form by the participant or their legal guardian.

Exclusion Criteria:

1. Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA);
2. Patients with an expected life expectancy of less than 1 year;
3. Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator;
4. 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;
5. Severe and persistent hypertension uncontrolled by medication ;
6. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L;
7. Active internal bleeding with a high risk of hemorrhage;
8. Any known coagulation disorder;
9. Known platelet function defect or platelet count less than 100×10⁹/L;

Where it's running

• Puyang Oilfield General Hospital
  Puyang, Henan, China Recruiting

Study contacts

• Study coordinator: Clinical Trials Information Group officer
• Email: ctr-contact@cspc.cn
• Phone: 031169085587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.