NCT07763405Not yet recruitingPhase 4
Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke
Efficacy and Safety of Lumbrokinase Versus Placebo in Moderate-to-Severe Ischemic Stroke: A Multicenter, Randomized, Double-Blind Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1196 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Diseases
- Stroke
- NCT number
- NCT07763405
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1196
- From Nov 2026 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received or planned intravenous thrombolysis or endovascular treatment after stroke onset;
- Concomitant use of other fibrinolytic therapy (e.g., urokinase, batroxobin, snake-venom preparations) or anticoagulant therapy (e.g., argatroban, rivaroxaban, dabigatran);
- Planned surgery or vascular reconstruction within 90 days that may require study-drug interruption;
- Received lumbrokinase or other fibrinolytic therapy within 14 days prior to randomization;
- Prior neurological or psychiatric disease that would interfere with neurological assessment;
Other illness
- 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.);
- 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;
- History of malignancy or aneurysm (including intracranial or peripheral aneurysm);
Lab values
- 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);
Other
- Accompanying hemorrhagic transformation of infarction;
- Pregnancy or lactation;
- Participation in another clinical trial;
- Expected survival less than 90 days;
- Expected inability to complete follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.