Health TrialsbyHealthPanel

Lumbrokinase vs Placebo in Moderate-to-Severe Ischemic Stroke

ConditionIschemic Stroke, Acute
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXinqiao Hospital of Chongqing

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

1,196 Participants
are divided into 2 treatment groups
Group A: Lumbrokinase + AspirinExperimental treatment 1 intervention
Group B: Placebo + AspirinPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

90-day mRS score distribution (ordinal shift analysis)

90-day mRS score distribution (ordinal shift analysis)

Time frame
At 90 days after randomization
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xinqiao Hospital of Chongqing

Lead sponsor

The First Affiliated Hospital of Nanchang University

Collaborator

Source ClinicalTrials.gov

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