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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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).
. 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.