NCT07519889

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (estimated)
• Sponsor: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, prospective, non-randomized, parallel-group, post-marketing safety surveillance cohort study conducted in routine clinical practice to compare the safety of intravenous thrombolysis with rhTNK-tPA (Mingfule®) versus rt-PA (Actilyse®) in patients with acute ischemic stroke. As a non-interventional observational study, no randomization or blinding is applied. The choice of thrombolytic agent is determined solely by the treating physician in accordance with clinical guidelines and individual patient circumstances. Patients are assigned to one of two groups based on the actual treatment received: rhTNK-tPA group: Administered 0.25 mg/kg (maximum 25 mg) as a single intravenous bolus injection per the approved package insert. rt-PA group: Administered 0.9 mg/kg per the approved package insert, with 10% of the total dose given as an intravenous bolus and the remaining 90% infused continuously over 60 minutes. The target sample size is approximately 4,500 patients, with about 3,000 in the rhTNK-tPA group and at least 1,500 in the rt-PA group. This sample size is selected to fulfill the regulatory requirements for post-marketing intensive monitoring and to ensure sufficient statistical precision for safety comparisons between the two treatment groups.

Conditions

• Acute Ischemic Stroke
• rhTNK-tPA

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2026-04-10
• Primary completion: 2027-01-10
• Completion: 2027-04-10
• First posted: 2026-04-09
• Last updated: 2026-04-09