Can an earthworm enzyme boost stroke recovery?
NCT ID NCT07763405
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial tests whether adding lumbrokinase, an enzyme derived from earthworms, to standard aspirin treatment can improve recovery in people who have had a moderate-to-severe ischemic stroke. Participants receive either lumbrokinase capsules or a placebo, along with aspirin, for up to 90 days. The study measures how many people achieve a good functional outcome (able to live independently) at 90 days, and also tracks any serious bleeding events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lumbrokinase (an enzyme from earthworms) taken as capsules, combined with aspirin
- What this could lead to
- If effective, this could offer a new oral treatment to improve functional recovery after a moderate-to-severe ischemic stroke, potentially reducing long-term disability.
- What could go wrong
- This is a phase 4 trial, but results are not yet known. The main risk is increased bleeding, and the benefit over standard aspirin therapy remains unproven until the data are analyzed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 1,196 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Nov 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Prior neurological or psychiatric disease that would interfere with neurological assessment; * Expected survival less than 90 days; * Expected inability to complete follow-up.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ischemic stroke, acute are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- AI as a second opinion for stroke: a smarter path to Clot-Busting?
- Can a Rapid-Acting clot blocker boost stroke recovery?
- Can a common antibiotic shield the brain after a stroke?
- Can a simple relaxation technique soothe the mind after a stroke?
- Stroke care at a distance: can video consultations speed up Life-Saving treatment?
- Herbal capsule may boost brain repair after stroke