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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
HRS-7450 Injection; low dose
HRS-7450 Injection; Intermediate dose
HRS-7450 Injection; high dose
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGLinyi People's Hospital
Linyi, Shandong, China
RECRUITINGmRS score of 0-1 at 90 days
Time frame: within 90 days after the start of administration
Reperfusion rate at 24 hours;
Time frame: within 24 hours after the start of administration
Recanalization rate at 24 hours;
Time frame: within 24 hours after the start of administration
Proportion of subjects with ≥8-point reduction in NIHSS score or NIHSS score of 0-1 at 24 hours;
Time frame: within 24 hours after the start of administration
Infarct volume at 7 days;
Time frame: 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;
Time frame: within 7 days after the start of administration
NIHSS score at 14 days;
Time frame: within 14 days after the start of administration
mRS score at 90 days;
Time frame: within 90 days after the start of administration
Proportion of subjects with mRS score 0-2 at 90 days;
Time frame: within 90 days after the start of administration
Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing;
Time frame: within 36 hours after the start of administration
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HRS-7450 Injection Placebo
Incidence of symptomatic intracranial hemorrhage (sICH) within 7 days after dosing;
Time frame: within 7 days after the start of administration
Incidence of intracranial hemorrhage (ICH) within 36 hours after dosing;
Time frame: within 36 hours after the start of administration
Incidence of intracranial hemorrhage (ICH) within 7 days after dosing;
Time frame: within 7 days after the start of administration
Incidence of major non-intracranial hemorrhage within 36 hours after dosing;
Time frame: within 36 hours after the start of administration
Incidence of major non-intracranial hemorrhage within 7 days after dosing;
Time frame: within 7 days after the start of administration
Mortality rate at 7 days after dosing;
Time frame: within 7 days after the start of administration
Mortality rate at 90 days after dosing;
Time frame: within 90 days after the start of administration