Stroke drug timing could boost recovery, study finds
NCT ID NCT06472921
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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204 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Nov 2025
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: 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
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Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
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Xiangya Hospital, Central South University
Changsha, China
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Other studies related to the condition(s) this trial covers.
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