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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Incidence of symptomatic intracerebral hemorrhage (defined according to the ECASS III criteria) within 36 hours after thrombolysis treatment [Срок оценки: Within 36 hours after thrombolysis treatment]

Вторичные конечные точки (5)

• Overall mortality rate at Day 90. [Срок оценки: At Day 90]
• Proportion of adverse drug reactions (ADRs) at Day 90. [Срок оценки: At Day 90]
• Proportion of serious adverse events (SAEs) at Day 90. [Срок оценки: At Day 90]
• Incidence of stroke recurrence at Day 90. [Срок оценки: At Day 90]
• Time to stroke recurrence [Срок оценки: At Day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07519889 · MK02-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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