Clinical Trial

Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke

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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.
Trial Details
NCT Number NCT07519889
Lead Sponsor CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Conditions Acute Ischemic Stroke, rhTNK-tPA
Enrollment 4,500 participants
Start Date 2026-04-10
Primary Completion 2027-01-10 (estimated)
Study Completion 2027-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-04-09