Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborator: Guangzhou Recomgen Biotech Co., Ltd.
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

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.