The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 236

Inclusion Criteria

The target population is 35-75 years old, regardless of gender;
within 6h of onset, ischemic stroke of the internal carotid artery system;
Neurological deficits, including limb weakness, with acute brain injury (NIHSS score) (4-22 points), or NIHSS item 5 upper limb or 6 lower limb score ≥2 points;
Be able to initiate study treatment within 6 hours of onset of symptoms or within 6 hours of last appearing normal (6 hours after sleep in subjects with ischemic stroke who developed during sleep) and complete post-onset CT examination prior to study treatment;
Obtain the informed consent signed by the subject or the subject's legal representative;
MRS score before onset was 0~1;
Patients with no history of myocardial infarction within 3 months;
Centerless, liver, kidney and lung dysfunction;
No hemorrhagic disease within 3 months;
No blood system diseases.

Exclusion Criteria

Any contraindications to CT or MRI (such as metal implants such as pacemaker, claustrophobia, etc
Stroke caused by posterior circulation ischemia, or TIA;
Acute intracranial hemorrhage, intracranial tumor, subarachnoid hemorrhage, encephalitis or other non-acute ischemic stroke (onset less than 6 hours), intracranial arteriovenous malformations;
Patients who plan to undergo endovascular treatment, such as mechanical thrombectomy, stenting or arteriovenous bridging, within 6 hours after onset;
Pregnant or lactating women. Note: The blood pregnancy test for fertile women before randomization must be negative and appropriate contraception should be used at least 3 weeks before randomization until 7 days after study drug infusion
A pre-existing medical, neurological or psychiatric disorder that confuses neurological, functional or imaging assessments, such as persistent injury from previous ischemic stroke;
Patients with malignant tumors or other critical diseases;
Having a history of epilepsy or having epileptiform symptoms at the onset of stroke;
Previous history of intracranial hemorrhage;
Patients with previous hypotension or blood pressure of less than 90/60mmhg measured for 3 consecutive times;
Patients with severe injuries and surgical history within 3 months;
People with consciousness disorder can be defined as "NIHSS score Ia ≥2 points";
Bradycardia with complete atrioventricular block;
According to the New York heart association (NYHA) grade of cardiac function, cardiac function rating above Ⅱ level, a history of congestive heart failure (CHF).
Patients with primary liver and kidney diseases, AST or ALT twice as high as the normal upper limit, serum creatinine >2.0 mg/dL or >176.8 mol/L;
Where the INR is greater than 1.7 or where an oral anticoagulant is currently used, except aspirin, clopidogrel, subcutaneous heparin or Wartamine;
Patients with bleeding tendency diseases (such as hemophilia), and partial thromboplastin time (PTT) is more than 3 times of the normal upper limit;
Having a current drug or alcohol problem or experience;
Has the experience of allergic reaction to the research drugs or drugs with similar chemical structure;
Participated in other clinical trials or clinical study participants within 3 months before the start of this study;
The researcher considered it inappropriate to participate in the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A ：low dose sofadil	sofadil【Neu2000KW】	500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
Group B: Medium dose group	Sofadil	750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
Group C: high dose group	Sofadil	1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
Group D: placebo group	placebo	Saline was administered intravenously

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a NIHSS score	14±2 days of treatment	Proportion of subjects with a NIHSS score of 0 \~ 1 or 4 or more points less than baseline NIHSS at 14±2 days of treatment

Secondary Outcome Measures

Name	Time	Method
Changes in NIHSS score	at 14±2, 30±2, and 90±7 days after treatment compared to baseline	Changes in NIHSS score at 14±2, 30±2, and 90±7 days after treatment compared to baseline

The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke

Recruitment & Eligibility

Study & Design

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