A Phase 4 interventional study of Lumbrokinase and Lumbrokinase Placebo in Ischemic Stroke, Acute, sponsored by Xinqiao Hospital of Chongqing. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Xinqiao Hospital of Chongqing · Phase 4, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,196 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xinqiao Hospital of Chongqing is the lead sponsor of 69 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Lumbrokinase
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.
Drug: Lumbrokinase Placebo
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.
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.
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
90-day mRS score distribution (ordinal shift analysis)
90-day mRS score distribution (ordinal shift analysis)
Time frame: At 90 days after randomization
Change in fibrinogen level from randomization to day 28
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
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
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
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
Proportion of participants with mRS 0-2 at 90 days
Time frame: At 90 days after randomization
90-day EQ-5D-5L score
90-day EQ-5D-5L score
Time frame: At 90 days after randomization
NIHSS score at 5-7 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)
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
Ischemic stroke recurrence rate within 90 days
Time frame: Within 90 days after randomization
Proportion with intracranial hemorrhage within 90 days
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
All-cause mortality within 90 days
Time frame: Within 90 days after randomization
Investigator-reported adverse events / serious adverse events within 90 days
Investigator-reported adverse events / serious adverse events within 90 days
Time frame: Within 90 days after randomization
No study locations are listed for this record.
Plan to share: Yes — Study data without patient information
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Related papers published 6 months later, the IPD will be shared
Access criteria: hongdaojun@hotmail.com
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 74 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 25 months is below that.
Counting every sponsor, half of 83 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Xinqiao Hospital of Chongqing