To assess the Efficacy and Safety of Dengzhanxixin Injection in Patients With Acute Ischemic Stroke Receiving Reperfusion Therapy.
To evaluate the safety and efficacy of Dengzhanxixin at different doses of 80ml/day, 40 ml/day, or placebo within 24 hours after the onset of ischemic stroke. The primary objective of this study is the proportion of subjects with excellent outcomes defined as mRS (0-1) among the three treatment groups at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Experimental arms for low, and high dose for the standard protocol
placebo control arm for the standard protocol
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Primary Efficacy Outcome
Proportion of subjects of excellent outcome defined as modified Rankin Scale (mRS) (0-1) at 90 days. mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
Time frame: 90 days
Primary Safety Outcome
Proportion of patients with adverse events at 90 days.
Time frame: 90 days
Infarction Volume
Infarction volume at 14 days compared to baseline
Time frame: 14 days
National Institutes of Health Stroke Scale (NIHSS)
National Institutes of Health Stroke Scale (NIHSS) score changes from baseline. NIHSS is 42 point scale where 0 is the best o and 42 is the worst outcome.
Time frame: 72 hours, 7 days, 14 days, 90days
Excellent functional outcome
Favourable outcome rate is defined as the proportion of subjects with modified Rankin Scale (mRS) (0-1). mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
Time frame: 14 days
Modified Rankin Scale (mRS) distribution
Ordinal distribution of Modified Rankin Scale (mRS). mRS is a 7 grade scale from 0 to 6, where 0 is the best and 6 is the worst outcome.
Time frame: 14 days, 90 days
Barthel index (BI)
Proportion of subjects with Global function of daily living defined as Change in Barthel index (BI) ≥ 95. BI is a 10 item scale with scores ranging from 0 to 100, where a score of 100 is the best and 0 is the worst outcome.
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Time frame: 90 days
Symptomatic intracranial hemorrhage(sICH)
Proportion of subjects with symptomatic intracranial hemorrhage (sICH)
Time frame: 14 days
AEs
Proportion of subjects with AEs
Time frame: 72 hours,7 days, 14 days
SAEs
Proportion of subjects with SAEs
Time frame: 72 hours,7 days, 14 days,90days