Overview

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.