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Stroke drug timing could boost recovery, study finds

NCT ID NCT06472921

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving the drug butylphthalide earlier (within 3 hours of a stroke) helps patients recover better than giving it later (3-6 hours). The trial involved 204 adults with acute ischemic stroke. Researchers measured recovery using standard disability and neurological scales to find the optimal treatment window.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

204 people

The number who actually took part.

Started

Jul 2024

Finished

Nov 2025

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: 1. Age between 18 and 80 years, gender not specified; 2. Clinically diagnosed with acute ischemic stroke; 3. Stroke onset within 3 hours; 4. NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point; 5. Pre-stroke mRS score ≤1 point; 6. Participants and their representatives capable and willing to sign an informed consent form. Exclusion Criteria: 1. Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma; 2. Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels \>3 times the upper limit of normal or AST levels \>3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \>3.0 mg/dl \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \<30 ml/min/1.73m²); 3. Systolic blood pressure \<90 mmHg or \>220 mmHg; 4. Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome; 5. History of drug or food allergies, including known allergies to the components of the study medication; 6. Treatment with medications containing Butylphthalide following the onset of the current stroke episode; 7. Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions; 8. Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days; 9. Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures; 10. Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days; 11. Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study; 12. Any other reason deemed by the investigator as unsuitable for participation in the study.

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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.

Contacts and locations

Locations

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008, China

  • Xiangya Hospital, Central South University

    Changsha, China

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