Could a common drug prevent brain swelling after stroke?
NCT ID NCT07528456
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug butylphthalide can reduce brain swelling in people who have had a severe stroke and undergone a procedure to reopen a blocked artery. About 100 adults will receive either the drug or a placebo for up to 14 days. Researchers will measure changes in spinal fluid and brain scans to see if the drug helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- butylphthalide
- What this could lead to
- If it works, this could point toward a new way to reduce dangerous brain swelling after a stroke, potentially improving recovery.
- What could go wrong
- This is a small, early-phase trial with only 100 people. The drug may not reduce swelling better than placebo, and side effects are possible.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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 years and older
- 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 ≥18 years. 2. Time from onset to randomization within 24 hours. 3. Confirmed occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery by digital subtraction angiography (DSA). 4. NIHSS score ≥10 at onset, or NIHSS score \>8 at 1 hour post-procedure (for those able to cooperate with NIHSS assessment), or CT-ASPECTS score 3-7 immediately post-procedure. 5. Received endovascular treatment with successful reperfusion (mTICI ≥2b). 6. Signed informed consent form by the subject or their legally authorized representative. Exclusion Criteria: 1. Pre-stroke modified Rankin Scale (mRS) score ≥2. 2. Immediate post-procedure CT indicating PH2 hemorrhagic transformation or subarachnoid hemorrhage. 3. Immediate post-procedure CT indicating cerebral herniation or planned decompressive craniectomy. 4. History or evidence of intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm, or brain tumor. 5. Evidence (clinical or radiological) of concurrent infarction in the contralateral cerebral hemisphere that, in the investigator's judgment, may affect functional prognosis. 6. Clinical or radiological evidence of vertebral or basilar artery occlusion. 7. History of severe renal impairment (e.g., on dialysis) or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²; severe hepatic disease or alanine aminotransferase (ALT) \>3× the upper limit of normal, or total bilirubin \>2× the upper limit of normal. 8. Use of butylphthalide within 7 days prior to enrollment. 9. Known allergy to butylphthalide. 10. Pregnancy. 11. Breastfeeding women who do not agree (or whose legally authorized representative does not allow) to discontinue breastfeeding during the study drug administration period and for 7 days thereafter. 12. Participation in other purely observational stroke studies, or expected survival \<6 months unrelated to the current stroke, or unlikely to comply with follow-up requirements. 13. Currently receiving another investigational drug with the same or similar mechanism of action as the study drug. 14. Any condition that, in the investigator's opinion, makes the subject 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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Dongguan People's Hospital
Dongguan, Guangdong, China
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Ganzhou People's Hospital
Ganzhou, Jiangxi, China
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Haikou People's Hospital
Haikou, Hainan, China
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Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan, China
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Heyuan People's Hospital
Heyuan, Guangdong, China
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
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Qingyuan People's Hospital
Qingyuan, Guangdong, China
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The Fourth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
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Yuebei People's Hospital
Shaoguan, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better