NCT06472921CompletedPhase 2
Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.
Effect of Early Initiation of Butylphthalide on Neural Function in Patients With Acute Ischemic Stroke -A Prospective, Multicenter, Randomized, Open-label, Blinded End Trial
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\<3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (actual)
- First submitted
- 19 Jun 2024
- Start date
- 29 Jul 2024
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- Stroke
- NCT number
- NCT06472921
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 204
- From 29 Jul 2024 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with medications containing Butylphthalide following the onset of the current stroke episode;
- Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days;
- Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study;
Other illness
- Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
- Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
- History of drug or food allergies, including known allergies to the components of the study medication;
- Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions;
- Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures;
Lab values
- 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);
Other
- Systolic blood pressure \<90 mmHg or \>220 mmHg;
- Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days;
- Any other reason deemed by the investigator as unsuitable for participation in the study.
Who the study is looking for
- Age between 18 and 80 years, gender not specified;
- Clinically diagnosed with acute ischemic stroke;
- Stroke onset within 3 hours;
- NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point;
- Pre-stroke mRS score ≤1 point;
- Participants and their representatives capable and willing to sign an informed consent form.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.