Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.

Más betegség

• 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;

Laborértékek

• Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L;
• Known platelet function defect or platelet count less than 100×10⁹/L;

Egyéb

• 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;

• 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.