Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

Phase 4Not Yet RecruitingNCT07763405

Xinqiao Hospital of Chongqing1,196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,196

Conditions

Ischemic Stroke, Acute

Interventions

Participants receive lumbrokinase enteric-coated capsules 600,000 IU per dose, three times daily, 30 minutes before meals, for 28 days, plus oral aspirin 100 mg once daily for 90 days. Study drug is started as soon as possible after randomization. Guideline-based standard medical care for acute ischemic stroke is provided throughout.

Lumbrokinase PlaceboDRUG

Participants receive matching placebo enteric-coated capsules (identical to lumbrokinase capsules in appearance, odor, taste, and packaging) 600,000 IU-equivalent per dose, three times daily, 30 minutes before meals, for 28 days, plus oral aspirin 100 mg once daily for 90 days. Guideline-based standard medical care for acute ischemic stroke is provided throughout.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of patients with mRS 0-1 at 90 days

Proportion of participants achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 (no symptoms) or 1 (no significant disability despite some symptoms) at 90 days after randomization.

Time frame: At 90 days after randomization

Incidence of severe or moderate bleeding (GUSTO definition) within 90 days

Proportion of participants experiencing severe or moderate bleeding within 90 days, assessed using the GUSTO bleeding classification.

Time frame: Within 90 days after randomization

Secondary Outcomes

90-day mRS score distribution (ordinal shift analysis)

Time frame: At 90 days after randomization

Change in fibrinogen level from randomization to day 28

Time frame: At 28 days after randomization

Change in hs-CRP level from randomization to day 28

Time frame: At 28 days after randomization

Change in prothrombin time (PT) from randomization to day 28

Time frame: At 28 days after randomization

Change in activated partial thromboplastin time (APTT) from randomization to day 28

Time frame: At 28 days after randomization

Proportion of participants with mRS 0-2 at 90 days

Time frame: At 90 days after randomization

90-day EQ-5D-5L score

Time frame: At 90 days after randomization

NIHSS score at 5-7 days after randomization

Time frame: At 5-7 days after randomization

Composite vascular events within 90 days (ischemic stroke, intracranial hemorrhage, myocardial infarction, vascular death)

Time frame: Within 90 days after randomization

Ischemic stroke recurrence rate within 90 days

Time frame: Within 90 days after randomization

Proportion with intracranial hemorrhage within 90 days

Time frame: Within 90 days after randomization

All bleeding events within 90 days

All bleeding events within 90 days (including severe/moderate bleeding and intracranial hemorrhage)

Time frame: Within 90 days after randomization

All-cause mortality within 90 days

Time frame: Within 90 days after randomization

Investigator-reported adverse events / serious adverse events within 90 days

Time frame: Within 90 days after randomization

Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts