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

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of sofadil injection in the treatment of acute ischemic stroke

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital

Criteria

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.