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This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-7450 Injection | Experimental |
| |
| Treatment group B: HRS-7450 Injection | Experimental |
| |
| Treatment group C: HRS-7450 Injection | Experimental |
| |
| Treatment group D: HRS-7450 Injection Placebo. | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7450 Injection | Drug | HRS-7450 Injection; low dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score of 0-1 at 90 days | within 90 days after the start of administration |
| Measure | Description | Time Frame |
|---|---|---|
| Reperfusion rate at 24 hours; | within 24 hours after the start of administration | |
| Recanalization rate at 24 hours; | within 24 hours after the start of administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510062 | China | ||
| Linyi People's Hospital |
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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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| HRS-7450 Injection |
| Drug |
HRS-7450 Injection; Intermediate dose |
|
| HRS-7450 Injection | Drug | HRS-7450 Injection; high dose |
|
| HRS-7450 Injection Placebo | Drug | HRS-7450 Injection Placebo |
|
| Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 24 hours; |
| within 24 hours after the start of administration |
| Infarct volume at 7 days; | within 7 days after the start of administration |
| Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 7 days; | within 7 days after the start of administration |
| NIHSS score at 14 days; | within 14 days after the start of administration |
| mRS score at 90 days; | within 90 days after the start of administration |
| Proportion of subjects with mRS score 0-2 at 90 days; | within 90 days after the start of administration |
| Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing; | within 36 hours after the start of administration |
| Incidence of symptomatic intracranial hemorrhage (sICH) within 7 days after dosing; | within 7 days after the start of administration |
| Incidence of intracranial hemorrhage (ICH) within 36 hours after dosing; | within 36 hours after the start of administration |
| Incidence of intracranial hemorrhage (ICH) within 7 days after dosing; | within 7 days after the start of administration |
| Incidence of major non-intracranial hemorrhage within 36 hours after dosing; | within 36 hours after the start of administration |
| Incidence of major non-intracranial hemorrhage within 7 days after dosing; | within 7 days after the start of administration |
| Mortality rate at 7 days after dosing; | within 7 days after the start of administration |
| Mortality rate at 90 days after dosing; | within 90 days after the start of administration |
| Linyi |
| Shandong |
| 276002 |
| China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |