Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial

A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours

To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

Inclusion Criteria:

• Age ≥18 years old, no gender limitation;
• The time from onset to treatment was < 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal";
• The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
• MRS before onset was 0-1 points
• Baseline NIHSS 5-25(both included);
• Informed consent from the patient or surrogate.

Exclusion Criteria:

• Intended to proceed endovascular treatment;
• NIHSS consciousness score >2;
• Allergy to tenecteplase or alteplase;
• Past history of intracranial hemorrhage ;
• A history of severe head trauma or stroke within 3 months;
• A history of intracranial or spinal surgery within 3 months;
• A history of gastrointestinal or urinary bleeding within 3 weeks;
• 2 weeks of major surgery;
• Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
• Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
• Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
• Active visceral bleeding;
• Aortic arch dissection was found;
• After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
• Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
• Blood glucose <2.8 mmol/L or >22.22 mmol/L;
• Oral warfarin anticoagulant with INR>1.7 or PT>15 s;
• Heparin treatment was received within 24 h;
• Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
• Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery);
• Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
• Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
• Participation in other clinical trials within 3 months prior to screening;
• Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.