A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke

TRANSIT is a prospective, multicenter, open-label real world study.The purpose of this study was to compare the safety, efficacy and economic benefits of recombinant human TNK tissue plasminogen activator (tenecteplase, rhTNK-tPA, TNK) and recombinant tissue plasminogen activator (alteplase, rtPA) in practical clinical applications. To provide the basis for optimizing the intravenous thrombolysis program for different types of patients, and to provide a reference for clinicians to choose the appropriate thrombolytic therapy program.

6000 individuals who met the indications for intravenous thrombolysis and signed informed consent were included.The enrolled patients received treatment with tenecteplase (rhTNK-tPA) at a dosage of 0.25 mg/kg, up to a maximum of 25 mg, or alteplase (rtPA) at a dosage of 0.9 mg/kg, up to a maximum of 90 mg, based on their clinical condition and the preferences expressed by the patients and their families. Assessments were conducted at baseline, as well as at 24, 36, and 72 hours post-thrombolysis. Follow-up evaluations were performed on day 7 (or prior to discharge) and day 90.The primary efficacy endpoint was the proportion of excellent functional outcomes at 90±7 days (modified Rankin Scale score, mRS 0 or 1).The primary safety outcome was the proportion of sICH within 36 h (as defined by The European Cooperative Acute Stroke Study III criteria).The economic endpoint included the total costs of the first hospitalization and the days at home within 90±7 days.

Inclusion criteria

• 1. Symptoms of neurological deficit caused by ischemic stroke; 2. The time from onset to treatment ≤4.5 hours; The time of onset of symptoms was defined as the time of last seen normal.

• Age ≥18 years old; 4. Signed informed consent by patients or their legally authorized representative.

Exclusion criteria

• 1. Any absolute contraindication to thrombolysis in the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023" 2.Allergy to TNK or alteplase 3.Participation in another clinical trial within the previous 3 months. 4.Other conditions deemed inappropriate for participation in this study.