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Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke
Sponsor: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Summary
This is a multicenter, prospective, non-randomized, post-marketing safety surveillance cohort study with rt-PA (Actilyse®) as the control. It is designed to evaluate the safety of intravenous thrombolysis with recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA, Mingfule®) compared with rt-PA (Actilyse®) in patients with acute ischemic stroke in the real-world setting. This is a non-interventional observational study with no randomization. Treatment decisions are made by treating physicians based on routine clinical practice and the patient's condition. Patients are naturally allocated to the rhTNK-tPA group or the rt-PA group according to the actual thrombolytic drug they receive.
Official title: A Multicenter, Prospective, Non-Randomized, Parallel-Group, Post-Marketing Observational Patient Registry Study to Evaluate the Safety of Intravenous Thrombolysis With Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule®) Compared With Recombinant Tissue Plasminogen Activator (Rt-PA, Actilyse®) in Patients With Acute Ischemic Stroke
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
4500
Start Date
2026-04-10
Completion Date
2027-04-10
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
rhTNK-tPA
The rhTNK-tPA (Mingfule®) is administered as an intravenous bolus injection at a dose of 0.25 mg/kg, with a maximum dose of 25 mg, in accordance with the approved package insert.
rt-PA
The rt-PA (Actilyse®) is administered intravenously at a dose of 0.9 mg/kg. The 10% of total dose is given as an intravenous bolus, and the remaining 90% is infused continuously over 60 minutes, in accordance with the approved package insert.