Status:
COMPLETED
Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd.
Subei People's Hospital of Jiangsu Province
Conditions:
Stroke
Cerebral Infarction
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
The present study is to investigate safety and efficacy of Neu2000, a multi-target neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent antioxidant, in acute ischemi...
Eligibility Criteria
Inclusion
- patients aged between 35 and 75 years;
- acute ischemic stroke patients in internal carotid artery system within 6 hours of onset;
- patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor leg score ≥2 of NIHSS;
- 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;
- Informed consent should be signed from the patient or patient's legally authorized representative;
- patients with premorbid mRS score of 0\~1;
- patients with no history of myocardial infarction within last 3 months;
- patients with no heart, liver, kidney and lung function deficit;
- patients with no hemorrhagic diseases within last 3 months;
- patients with no haematological diseases.
Exclusion
- Any contraindication to CT and MRI (e.g., metal implants such as pacemakers, claustrophobia);
- Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);
- Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or other non-acute ischemic stroke and cerebral arteriovenous malformation;
- Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent angioplasty or arteriovenous bridge treatment;
- 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;
- Pre-existing medical, neurologic, or psychiatric diseases that would confound the neurologic, functional, or imaging evaluations, such as persistent deficit from previous ischemic stroke;
- Malignant tumor or other critical disease;
- Patients with a history of epilepsy or undergoing seizure on onset of the ischemic stroke
- A history of intracranial hemorrhage;
- Patients with low blood pressure, or showing blood pressure lower than 90/60mmHg in three consecutive times after admission;
- A history of severe injury and surgical operation within the last 3 months;
- Consciousness disorder as defined as "NIHSS Ia score ≥2 ";
- Complete atrioventricular block bradycardia;
- Cardiac function rating above II level according to the New York heart association (NYHA) grade of cardiac function, history of congestive heart failure (CHF);
- 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;
- International normalized ratio (INR) \> 1.7 or current use of oral anticoagulants, except aspirin, clopidogrel, subcutaneous heparin or warfarin;
- With bleeding tendency disease (such as hemophilia), partial thromboplastin time (PTT) \> 3 ×the upper limit of normal;
- A history of, or known current problems with, drug or alcohol abuse;
- A irritability experience of the study drugs or drugs with similar chemical structures;
- Participation in other clinical trials or studies before this study within the last 3 months;
- Researchers consider that patients don't suit for the study.
- Hepatitis B and C, HIV-positive patients
- Imaging exclusion criteria:
- patients with high density lesions associated with haemorrhage on CT scan after admission;
- patients with significant lower density lesions of 1/3 middle cerebral artery on CT scan after admission;
- patients with intracranial parenchymal tumors on CT scan after admission.
Key Trial Info
Start Date :
March 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04486430
Start Date
March 2 2017
End Date
December 13 2019
Last Update
July 24 2020
Active Locations (1)
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1
Beijing Stroke Association
Beijing, Beijing Municipality, China, 100050