Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

LUMEN is a multicenter, randomized, double-blind, placebo-controlled superiority trial designed to evaluate whether oral lumbrokinase enteric-coated capsules combined with aspirin improve functional outcomes compared with aspirin alone in patients with moderate-to-severe acute ischemic stroke. Eligible adults aged 18-80 years with a baseline NIHSS score of 4-20, prestroke mRS ≤1, and onset within 24 hours are randomly assigned 1:1 to receive either lumbrokinase (600,000 IU, three times daily for 28 days) plus aspirin 100 mg daily for 90 days, or matching placebo plus aspirin 100 mg daily for 90 days. All participants receive standard medical care according to guidelines. The primary efficacy endpoint is the proportion of patients achieving an excellent functional outcome (modified Rankin Scale score 0-1) at 90 days. The primary safety endpoint is the incidence of severe or moderate bleeding (GUSTO definition) within 90 days.

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 \