Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

NCT07763405 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: LUMEN
• Study Type: interventional
• Target: 1,196
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 90 days after randomization

Secondary Outcomes (14)

• 90-day mRS score distribution (ordinal shift analysis)

  At 90 days after randomization

• Change in fibrinogen level from randomization to day 28

  At 28 days after randomization

• Change in hs-CRP level from randomization to day 28

  At 28 days after randomization

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

  At 28 days after randomization

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

  At 28 days after randomization

Study Arms (2)

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.

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.

Drug: Lumbrokinase Placebo

Interventions

Lumbrokinase DRUG

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 + Aspirin

Lumbrokinase Placebo DRUG

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.

Placebo + Aspirin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• The First Affiliated Hospital of Nanchang University: collaborator

Related Publications (2)

• 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.

  PMID: 35410433 BACKGROUND

• del 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.

  PMID: 19299642 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

lumbrokinase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhongming Qiu

  Xinqiao Hospital of the Army Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daojun Hong, MD

CONTACT

+8613879187691; hongdaojun@hotmail.com

Jing Lin, MD

CONTACT

linjingsys2016@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Related papers published 6 months later, the IPD will be shared
• Access Criteria: hongdaojun@hotmail.com