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Can an earthworm enzyme boost stroke recovery?

NCT ID NCT07763405

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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Other studies related to the condition(s) this trial covers.