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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early initiation group | Experimental | Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. |
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| Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml | Other | Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butylphthalide treatment initiation time | Behavioral | Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group (<3 hours) and a late initiation group (3-6 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with an mRS score of 0-2 | 90±7 days post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with an mRS score of 0-1 | 90±7 days post-randomization | |
| Changes in NIHSS scores | at 6±1 days and 12±2 days compared to baseline | |
| Proportion of participants with an improvement of ≥4 points in NIHSS scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Changsha | Hunan | 410008 | China | ||
| Xiangya Hospital, Central South University |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Eligible participants with acute ischemic stroke will be randomly assigned in a 1:1 ratio to two groups: an early initiation group and a late initiation group.
Early initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins within 3 hours, administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.
Late initiation group: Treatment with Butylphthalide Sodium Chloride Injection begins between 3-6 hours, also administered at 100ml per dose, infused twice daily for a continuous period of 10-14 days.
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| at 6±1 days and 12±2 days |
| Early neurological deterioration | at 24±2 hours and 6±1 days post-randomization |
| Proportion of participants with ineffective recanalization | at 90±7 days post-randomization |
| Proportion of participants with recurrent ischemic stroke | at 90±7 days post-randomization |
| Proportion of combined vascular events (recurrent stroke, myocardial infarction, and vascular death) | at 90±7 days post-randomization |
| Difference in cerebral infarction volume size | between baseline and 12±2 days post-randomization |
| Quality of life (EQ-5D) scores | at 90±7 days post-randomization |
| Changsha |
| China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |