Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treati… (NCT07519889) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke
4,500 participantsStarted 2026-04-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients aged 18 years or older.
✓. Time from symptom onset to treatment \< 4.5 hours, with the time of symptom onset defined as "last known normal time".
✓. Meet the diagnostic criteria for acute ischemic stroke, confirmed by imaging (head CT or MRI).
✓. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≤ 25 points at admission.
✓. Planned to receive intravenous thrombolysis with either rhTNK-tPA (Mingfule®) 0.25 mg/kg or rt-PA (Actilyse®) 0.9 mg/kg.
✓. Voluntary signing of the informed consent form by the participant or their legal guardian.
✓. Have complete clinical and imaging data, and be able to cooperate with follow-up assessments.
Exclusion criteria
✕. Patients with absolute contraindications to reperfusion therapy (including intravenous thrombolysis and mechanical thrombectomy), specifically:
✕. Known pregnant or lactating female patients (judged by the investigator based on last menstrual period, medical history, or patient/family report).
What they're measuring
1
Incidence of symptomatic intracerebral hemorrhage (defined according to the ECASS III criteria) within 36 hours after thrombolysis treatment
Timeframe: Within 36 hours after thrombolysis treatment
✕. Patients who have received prior reperfusion therapy outside the hospital (including intravenous thrombolysis and endovascular treatment).
✕. Patients expected to be unable to complete follow-up (e.g., predicted survival \< 3 months, or inability to comply with follow-up plans for other reasons).
✕. Patients participating in other clinical trials where the interventions may affect the results of this study.