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

NCT07519889 | Not Yet Recruiting

• 1 other identifier: MK02-004
• Study Type: observational
• Target: 4,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Ischemic Stroke; rhTNK-tPA

Keywords

Acute Ischemic Stroke; rhTNK-tPA

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 36 hours after thrombolysis treatment

Secondary Outcomes (5)

• Overall mortality rate at Day 90.

  At Day 90

• Proportion of adverse drug reactions (ADRs) at Day 90.

  At Day 90

• Proportion of serious adverse events (SAEs) at Day 90.

  At Day 90

• Incidence of stroke recurrence at Day 90.

  At Day 90

• Time to stroke recurrence

  At Day 90

Other Outcomes (3)

• Proportion of participants with mRS score of 0-1 at Day 90.

  At Day 90

• Proportion of participants with mRS score of 0-2 at Day 90.

  At Day 90

• The full ordinal distribution of Modified Rankin Scale (mRS) score at Day 90.

  At Day 90

Study Arms (2)

rhTNK-tPA group

Drug: rhTNK-tPA

rt-PA group

Drug: rt-PA

Interventions

rt-PA DRUG

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.

rt-PA group

rhTNK-tPA DRUG

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.

rhTNK-tPA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 9, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): April 10, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04