Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset

• Status: Completed
• Trial end date: 2019-12-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset.

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

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborators: Daqing Oil Field Hospital; First Affiliated Hospital of Jinan University; First Affiliated Hospital of Wenzhou Medical University; First Affiliated Hospital of Zhejiang University; First Hospital of China Medical University; First Hospital of Jilin University; General Hospital of Shenyang Military Region; Guangzhou First People's Hospital; Hebei General Hospital; Hebei Medical University Third Hospital; Inner Mongolia Baogang Hospital; Nanfang Hospital of Southern Medical University; Nanjing PLA General Hospital; Peking University First Hospital; Peking University Third Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital of Guangzhou Medical University; Second Affiliated Hospital, School of Medicine, Zhejiang University; Second Hospital of Shanxi Medical University; Shandong Provincial Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Minhang Central Hospital; Shanghai Pudong New Area People's Hospital; Subei People's Hospital of Jiangsu Province; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The Central Hospital of Lishui City; The First Affiliated Hospital of BaoTou Medical College; The First Affiliated Hospital of Soochow University; The First Hospital of Jilin University; The Second Hospital of Hebei Medical University; Tianjin First Central Hospital; Tianjin Huanhu Hospital; Tongji Hospital; Xiangya Hospital of Central South University; Xuanwu Hospital, Beijing; Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd.
• Treatments: Salicylates

Criteria

Inclusion Criteria:

1. patients aged between 35 and 75 years;

2. acute ischemic stroke patients in internal carotid artery system within 6 hours of onset;

3. patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor leg score ≥2 of NIHSS;

4. patients within 6 hours of onset or the last time known to be symptom free (within 6 hours of the start of sleep for ischemic stroke patients with onset during sleep), and who receive a CT test before the clinical study;

5. Informed consent should be signed from the patient or patient's legally authorized representative;

6. patients with premorbid mRS score of 0~1;

7. patients with no history of myocardial infarction within last 3 months;

8. patients with no heart, liver, kidney and lung function deficit;

9. patients with no hemorrhagic diseases within last 3 months;

10. patients with no haematological diseases.

Exclusion Criteria:

1. Any contraindication to CT and MRI (e.g., metal implants such as pacemakers, claustrophobia);

2. Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);

3. Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or other non-acute ischemic stroke and cerebral arteriovenous malformation;

4. Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent angioplasty or arteriovenous bridge treatment;

5. Pregnant or lactating women. Note: the pregnancy test of fertile women must be negative before randomization into groups, and female patients must take appropriate contraceptive methods at least for 3 weeks prior to the clinical study and over the next 7 days following the last injection of test drugs;

6. Pre-existing medical, neurologic, or psychiatric diseases that would confound the neurologic, functional, or imaging evaluations, such as persistent deficit from previous ischemic stroke;

7. Malignant tumor or other critical disease;

8. Patients with a history of epilepsy or undergoing seizure on onset of the ischemic stroke

9. A history of intracranial hemorrhage;

10. Patients with low blood pressure, or showing blood pressure lower than 90/60mmHg in three consecutive times after admission;

11. A history of severe injury and surgical operation within the last 3 months;

12. Consciousness disorder as defined as "NIHSS Ia score ≥2 ";

13. Complete atrioventricular block bradycardia;

14. Cardiac function rating above II level according to the New York heart association (NYHA) grade of cardiac function, history of congestive heart failure (CHF);

15. With primary liver and kidney disease, AST or ALT 2 times greater than upper normal limit, serum creatinine >2.0 mg/dL or >176.8 µmol/L;

16. International normalized ratio (INR) > 1.7 or current use of oral anticoagulants, except aspirin, clopidogrel, subcutaneous heparin or warfarin;

17. With bleeding tendency disease (such as hemophilia), partial thromboplastin time (PTT) > 3 ×the upper limit of normal;

18. A history of, or known current problems with, drug or alcohol abuse;

19. A irritability experience of the study drugs or drugs with similar chemical structures;

20. Participation in other clinical trials or studies before this study within the last 3 months;

21. Researchers consider that patients don't suit for the study.

22. Hepatitis B and C, HIV-positive patients

Imaging exclusion criteria:

1. patients with high density lesions associated with haemorrhage on CT scan after admission;

2. patients with significant lower density lesions of 1/3 middle cerebral artery on CT scan after admission;

3. patients with intracranial parenchymal tumors on CT scan after admission.