Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

Inclusion criteria

• Age 18-80 years;
• Acute ischemic stroke confirmed by CT or MRI;
• Baseline NIHSS score 4-20 at enrollment;
• Good prestroke functional status (mRS ≤1);
• Randomization within 24 hours of last known well;
• Written informed consent provided by the participant or legal representative.

Exclusion criteria

• Received or planned intravenous thrombolysis or endovascular treatment after stroke onset;
• Cardioembolic stroke (atrial fibrillation, heart valve replacement, atrial myxoma, endocarditis, etc.);
• Other causative etiologies of stroke (aortic dissection, cervico-cerebral arterial dissection, vasculitis, vascular malformation, moyamoya disease/syndrome, fibromuscular dysplasia, etc.);
• Non-vascular neurological diseases (intracranial tumor, multiple sclerosis, etc.);
• Accompanying hemorrhagic transformation of infarction;
• Concomitant use of other fibrinolytic therapy (e.g., urokinase, batroxobin, snake-venom preparations) or anticoagulant therapy (e.g., argatroban, rivaroxaban, dabigatran);
• Severe hepatic insufficiency (ALT or AST >2 × upper limit of normal) or renal insufficiency (creatinine >1.5 × ULN or eGFR <40 mL/min/1.73 m²), or coagulopathy, or systemic bleeding, or thrombocytopenia (<100×10⁹/L);
• History of intracranial hemorrhage (e.g., intracerebral hemorrhage or subarachnoid hemorrhage);
• Bleeding diathesis or major surgery within 90 days (gastrointestinal bleeding, hemoptysis, etc.);
• Hypersensitivity to lumbrokinase or aspirin;
• Planned surgery or vascular reconstruction within 90 days that may require study-drug interruption;
• History of malignancy or aneurysm (including intracranial or peripheral aneurysm);
• Received lumbrokinase or other fibrinolytic therapy within 14 days prior to randomization;
• Pregnancy or lactation;
• Participation in another clinical trial;
• Prior neurological or psychiatric disease that would interfere with neurological assessment;
• Expected survival less than 90 days;
• Expected inability to complete follow-up.