Acute Ischemic StrokeNCT07519889
Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and rhTNK-tPA, run by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, rhTNK-tPA
- What is being tested?
- rhTNK-tPA and rt-PA
- Type of treatment
- Injection or infusion
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 10 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients diagnosed with acute ischemic stroke (AIS) who present to the emergency departments or stroke centers of participating hospitals in China. This cohort includes individuals who are eligible for intravenous thrombolysis (IVT) within the standard therapeutic time window and are treated with rhTNK-tPA or rt-PA in a real-world clinical setting.
Who may be able to join
- 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.
Who cannot join
- Patients with absolute contraindications to reperfusion therapy (including intravenous thrombolysis and mechanical thrombectomy), specifically:
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.) History of prior intracranial hemorrhage Severe head trauma or stroke within the past 3 months Intracranial tumor or giant intracranial aneurysm Intracranial or intraspinal surgery within the past 3 months Major surgical procedure within the past 2 weeks Gastrointestinal or urinary tract bleeding within the past 3 weeks Active visceral bleeding Aortic arch dissection Arterial puncture at a non-compressible site within the past 1 week 11 Elevated blood pressure: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg 12 Acute bleeding diathesis, including platelet count < 100×10⁹/L or other conditions 13 Treatment with low molecular weight heparin within the past 24 hours 14 Oral anticoagulant use (warfarin) with INR > 1.7 or PT > 15 seconds 15 Use of thrombin inhibitors or factor Xa inhibitors within the past 48 hours, or abnormal laboratory tests deemed by the investigator to contraindicate thrombolysis (e.g., APTT, INR, platelet count, ECT, TT, or factor Xa activity assay) 16 Random blood glucose < 2.8 mmol/L or > 22.22 mmol/L 17 Head CT or MRI showing large-area infarction (infarct volume > 1/3 of the middle cerebral artery territory)
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- rhTNK-tPA, rt-PA
- Keywords
- Acute Ischemic Stroke, rhTNK-tPA
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPADrug
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-PADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| rhTNK-tPA group | Not described Receives: Drug: rhTNK-tPA | |
| rt-PA group | Not described Receives: Drug: rt-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic intracerebral hemorrhage (defined according to the ECASS III criteria) within 36 hours after thrombolysis treatment
Defined by ECASS III: any intraparenchymal or intracranial hemorrhage associated with clinical deterioration, where the latter is defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale [NIHSS] score or death, with confirmation that the hemorrhage is the cause of neurological deterioration.
Measured: Within 36 hours after thrombolysis treatment
Secondary outcomes (5)
Overall mortality rate at Day 90.
The proportion of randomized patients who died within 90 days
Measured: At Day 90
Proportion of adverse drug reactions (ADRs) at Day 90.
An adverse drug reactions (ADR) refers to any untoward medical occurrence that is judged to be causally related to the use of the study drug. All adverse events related to drug overdose or medication error shall be regarded as ADRs
Measured: At Day 90
Proportion of serious adverse events (SAEs) at Day 90.
A Serious Adverse Event (SAE) refers to a special safety event among AEs that meets any of the following criteria: "resulting in death, life-threatening, requiring hospitalization/prolongation of existing hospitalization, causing permanent or severe disability/incapacity, leading to congenital anomalies/birth defects, or being another important medical event.
Measured: At Day 90
Incidence of stroke recurrence at Day 90.
Percentage of participants experiencing a new or worsening acute ischemic stroke event occurring after initial thrombolysis treatment through Day 90.
Measured: At Day 90
Time to stroke recurrence
The time interval from the start of thrombolysis treatment to the first occurrence of stroke recurrence within 90 days.
Measured: At Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519889
- Sponsor's protocol ID
- MK02-004
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07519889
- Acronym / sponsor ID
- MK02-004
- Conditions
- Acute Ischemic Stroke, rhTNK-tPA
- Keywords
- Acute Ischemic Stroke, rhTNK-tPA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTNK-tPA group | – | Drug: rhTNK-tPA |
| rt-PA group | – | Drug: rt-PA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with acute ischemic stroke (AIS) who present to the emergency departments or stroke centers of participating hospitals in China. This cohort includes individuals who are eligible for intravenous thrombolysis (IVT) within the standard therapeutic time window and are treated with rhTNK-tPA or rt-PA in a real-world clinical setting.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients with absolute contraindications to reperfusion therapy (including intravenous thrombolysis and mechanical thrombectomy), specifically:
- Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.) History of prior intracranial hemorrhage Severe head trauma or stroke within the past 3 months Intracranial tumor or giant intracranial aneurysm Intracranial or intraspinal surgery within the past 3 months Major surgical procedure within the past 2 weeks Gastrointestinal or urinary tract bleeding within the past 3 weeks Active visceral bleeding Aortic arch dissection Arterial puncture at a non-compressible site within the past 1 week 11 Elevated blood pressure: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg 12 Acute bleeding diathesis, including platelet count < 100×10⁹/L or other conditions 13 Treatment with low molecular weight heparin within the past 24 hours 14 Oral anticoagulant use (warfarin) with INR > 1.7 or PT > 15 seconds 15 Use of thrombin inhibitors or factor Xa inhibitors within the past 48 hours, or abnormal laboratory tests deemed by the investigator to contraindicate thrombolysis (e.g., APTT, INR, platelet count, ECT, TT, or factor Xa activity assay) 16 Random blood glucose < 2.8 mmol/L or > 22.22 mmol/L 17 Head CT or MRI showing large-area infarction (infarct volume > 1/3 of the middle cerebral artery territory)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTNK-tPAThe 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 | rhTNK-tPA group |
| rt-PAThe 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. | Drug | rt-PA group |
Primary outcome
Incidence of symptomatic intracerebral hemorrhage (defined according to the ECASS III criteria) within 36 hours after thrombolysis treatment
Time frame: Within 36 hours after thrombolysis treatment
Defined by ECASS III: any intraparenchymal or intracranial hemorrhage associated with clinical deterioration, where the latter is defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale [NIHSS] score or death, with confirmation that the hemorrhage is the cause of neurological deterioration.
5 secondary outcomes
Overall mortality rate at Day 90.
Time frame: At Day 90
Proportion of adverse drug reactions (ADRs) at Day 90.
Time frame: At Day 90
Proportion of serious adverse events (SAEs) at Day 90.
Time frame: At Day 90
Incidence of stroke recurrence at Day 90.
Time frame: At Day 90
Time to stroke recurrence
Time frame: At Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongjun Wang, MD principal investigator
Beijing Tiantan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and rhTNK-tPA, run by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic intracerebral hemorrhage (defined according to the ECASS III criteria) within 36 hours after thrombolysis treatment (time frame: Within 36 hours after thrombolysis treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.