Overview

SPT-07A Injection in Patients With Acute Ischemic Stroke (AIS): A Phase III Clinical Trial

Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel controlled clinical trial in Chinese patients with acute ischemic stroke. Objective to evaluate the efficacy and safety of SPT-07A injection compared with placebo in the treatment of patients with acute ischemic stroke.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wuhan Union Hospital, China
Collaborators:
Affiliated hospital of jining medical college
Affiliated Hospital of Qingdao University
Beijing Haijinge Pharmaceutical Technology Co., Ltd
Changjiang Shipping General Hospital
Daqing oilfield general hospital
Daqing people's Hospital
Deyang People's Hospital
Dezhou People's Hospital
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Fujian Zhangzhou hospital
Fukuang General Hospital of Liaoning health industry group
Guangzhou Red Cross Hospital
Hainan People's Hospital
Hengshui People's Hospital
Huanggang Central Hospital
Inner Mongolia Baogang Hospital
Jiangsu Taizhou People's Hospital
Jiaxing First Hospital
Jingzhou Central Hospital
Linfen Central Hospital
Meihekou Central Hospital
Nanyang nanshai hospital
Neijiang Second People's Hospital
People's Hospital of Wuhan University
Qingdao Central Hospital
Qujing first people's Hospital
Shanghai Canming Pharmaceutical Technology Co., Ltd
Sinopharm Dongfeng General Hospital
Suzhou Huyun New Drug Research and Development Co., Ltd
Taian Central Hospital
Taizhou Municipal Hospital
Tancheng first people's Hospital
The Affiliated Hospital of Inner Mongolia Medical University
The Affiliated Hospital of Xuzhou Medical University
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
The First Affiliated Hospital of Hebei North University
The First Affiliated Hospital of Nanhua University
The First Affiliated Hospital of Nanyang Medical College
The First Affiliated Hospital of Shihezi University Medical College
The First Hospital of Jilin University
The Fourth Affiliated Hospital of Harbin Medical University
The Third Affiliated Hospital of Qiqihar Medical College
Tianjin People's Hospital
Weihai Municipal Hospital
Wuhan Central Hospital
Wuhan NO. 4 hospital
Xi'an Gaoxin Hospital
Xiang Yang NO.1 People's Hospital
Xiangtan Central Hospital
Xiangyang Central Hospital
Xuancheng people's hospital
Xuzhou Central Hospital
Yan'an University Xianyang hospital Co., Ltd
Yantai Yuhuangding Hospital
Yichang Central People's Hospital
Zhejiang Taizhou hospital
Zhongshan Hospital Xiamen University
Criteria
Inclusion Criteria:

1. Males or females aged 18 to 85 years;

2. According to the Key points for diagnosis of various major cerebrovascular diseases in
China 2019 and combined with the experience of clinicians, patients with ischemic
stroke were diagnosed;

3. From "the last time that looks normal" to the beginning of drug treatment ≤ 48 hours.
When the onset time of symptoms can not be accurately obtained after awakening stroke
or due to aphasia, disturbance of consciousness and other reasons, the final time of
normal performance of patients should be taken as the criterion.

4. First onset of ischemic stroke or prestroke with mRS of 0 or 1;

5. A National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20, and a
total score of upper and lower limbs ≥2 on motor deficits;

6. Capable of understanding the purpose and risk of the study and has signed, in writing,
the informed consent form (ICF). If the subject is not capable of this at the time of
enrollment, a legally authorized representative (LAR) will provide written informed
consent in accordance with all regulations.

Exclusion Criteria:

1. Serious disturbance of consciousness (NIHSS 1a ≥2 score);

2. Based on the opinion of the Investigator, the posterior circulation symptoms like
ataxia in stroke patients are caused by posterior circulation ischemia, such as
brainstem or cerebellum;

3. Neuroimaging (CT/MRI) revealed intracranial hemorrhagic diseases (such as cerebral
hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricular
hemorrhage, traumatic cerebral hemorrhage, etc.);

4. Rapidly improving or resolving symptoms, suggesting a possible transient ischemic
attack (TIA) rather than a qualifying stroke;

5. Subjects who are ready to undergo or have undergone intravenous thrombolysis, or
endovascular therapy in 90 days from onset;

6. Renal insufficiency: Serum creatinine > 2.5 times the upper limit of normal value, or
other known serious renal insufficiency diseases;

7. Liver function damage: ALT and AST > 2.5 times the upper limit of normal value, or
other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc.;

8. Poorly controlled hypertension, with systolic blood pressure (≥ 180 mmHg) and/or
diastolic blood pressure ( ≥110 mmHg);

9. Subjects with heart rate < 40 beats/min and/or heart rate > 120 beats/min; 2-degree or
3-degree cardiac block without pacemaker or other malignant arrhythmia; acute
myocardial infarction or interventional therapy in the past month, patients with heart
failure (according to NYHA grade III-IV);

10. Patients with status epilepticus who are unable to cooperate or unwilling to cooperate
due to other organic mental disorders and moderate or severe cognitive impairment;

11. Subjects with malignant tumors, serious diseases of the blood, digestive or other
systems or hemophilia and the expected survival time is not more than 3 months;

12. Female subjects who are pregnant, lactating/breast-feeding, or plan to become
pregnant;

13. Allergic constitution, or allergic to experimental drugs, analogous drugs or basic
treatment drugs;

14. Received treatment with any other investigational drug within 30 days before Baseline,
or is currently participating in another clinical study;

15. Any other reasons that, in the opinion of the investigator, make the subject
unsuitable for enrollment.