Ischemic Stroke, AcutePhase 4NCT07763405
Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke
A Phase 4 study testing Lumbrokinase in people with Ischemic Stroke, Acute, run by Xinqiao Hospital of Chongqing.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Lumbrokinase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,196 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 18Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jing Lin, MD contact
About this study
Official title: Efficacy and Safety of Lumbrokinase Versus Placebo in Moderate-to-Severe Ischemic Stroke: A Multicenter, Randomized, Double-Blind Clinical Trial
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.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Lumbrokinase, Lumbrokinase Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumbrokinaseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbrokinase + Aspirin | Experimental | 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. Receives: Drug: Lumbrokinase |
| Placebo + Aspirin | Placebo comparator | 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. Receives: Drug: Lumbrokinase Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 90 days after randomization
Secondary outcomes (14)
90-day mRS score distribution (ordinal shift analysis)
90-day mRS score distribution (ordinal shift analysis)
Measured: At 90 days after randomization
Change in fibrinogen level from randomization to day 28
Change in fibrinogen level from randomization to day 28
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 90 days after randomization
90-day EQ-5D-5L score
90-day EQ-5D-5L score
Measured: At 90 days after randomization
NIHSS score at 5-7 days after randomization
NIHSS score at 5-7 days after randomization
Measured: 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)
Measured: Within 90 days after randomization
Ischemic stroke recurrence rate within 90 days
Ischemic stroke recurrence rate within 90 days
Measured: Within 90 days after randomization
Proportion with intracranial hemorrhage within 90 days
Proportion with intracranial hemorrhage within 90 days
Measured: Within 90 days after randomization
All bleeding events within 90 days
All bleeding events within 90 days (including severe/moderate bleeding and intracranial hemorrhage)
Measured: Within 90 days after randomization
All-cause mortality within 90 days
All-cause mortality within 90 days
Measured: 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
Measured: Within 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
- Investigators
- Zhongming Qiu, Principal investigator, Xinqiao Hospital of the Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763405
- Sponsor's protocol ID
- LUMEN
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data without patient information
Publications
Chen Y, Liu Y, Zhang J, Zhou K, Zhang X, Dai H, Yang B, Shang H. Efficacy and safety of lumbrokinase plus aspirin versus aspirin alone for acute ischemic stroke (LUCENT): study protocol for a multicenter randomized controlled trial. Trials. 2022 Apr 11;23(1):285. doi: 10.1186/s13063-022-06200-4.
PubMed 35410433del Zoppo GJ, Levy DE, Wasiewski WW, Pancioli AM, Demchuk AM, Trammel J, Demaerschalk BM, Kaste M, Albers GW, Ringelstein EB. Hyperfibrinogenemia and functional outcome from acute ischemic stroke. Stroke. 2009 May;40(5):1687-91. doi: 10.1161/STROKEAHA.108.527804. Epub 2009 Mar 19.
PubMed 19299642
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lumbrokinase Versus Placebo in Moderate-to-Severe Ischemic Stroke: A Multicenter, Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07763405
- Acronym / sponsor ID
- LUMEN
- Conditions
- Ischemic Stroke, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,196 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbrokinase + Aspirin | Experimental | Drug: LumbrokinaseParticipants 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. |
| Placebo + Aspirin | Placebo comparator | Drug: Lumbrokinase PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumbrokinaseParticipants 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 + Aspirin |
| Lumbrokinase PlaceboParticipants 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 | Placebo + Aspirin |
Primary outcome
Proportion of patients with mRS 0-1 at 90 days
Time frame: At 90 days after randomization
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.
Incidence of severe or moderate bleeding (GUSTO definition) within 90 days
Time frame: Within 90 days after randomization
Proportion of participants experiencing severe or moderate bleeding within 90 days, assessed using the GUSTO bleeding classification.
14 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 35410433Chen Y, Liu Y, Zhang J, Zhou K, Zhang X, Dai H, Yang B, Shang H. Efficacy and safety of lumbrokinase plus aspirin versus aspirin alone for acute ischemic stroke (LUCENT): study protocol for a multicenter randomized controlled trial. Trials. 2022 Apr 11;23(1):285. doi: 10.1186/s13063-022-06200-4.
- Background: PubMed 19299642del Zoppo GJ, Levy DE, Wasiewski WW, Pancioli AM, Demchuk AM, Trammel J, Demaerschalk BM, Kaste M, Albers GW, Ringelstein EB. Hyperfibrinogenemia and functional outcome from acute ischemic stroke. Stroke. 2009 May;40(5):1687-91. doi: 10.1161/STROKEAHA.108.527804. Epub 2009 Mar 19.
- Individual participant dataSharing planned: Yes. Study data without patient information
Related trials for Ischemic Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Lin, MD contact
Zhongming Qiu principal investigator
Xinqiao Hospital of the Army Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumbrokinase in people with Ischemic Stroke, Acute, run by Xinqiao Hospital of Chongqing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daojun Hong, MD (+8613879187691, hongdaojun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS 0-1 at 90 days (time frame: At 90 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07763405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.