SPT-07A Injection in Patients With Acute Ischemic Stroke (AIS): A Phase III Clinical Trial
NCT ID: NCT05159947
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1112 participants
INTERVENTIONAL
2022-01-20
2024-01-10
Brief Summary
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Detailed Description
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During the treatment period, all subjects will receive SPT-07A injection or placebo by intravenous drip, twice a day for 7 consecutive days. During the treatment, all subjects need to receive basic treatment: citicoline sodium injection 0.25g, intravenous drip slowly, once a day, continuous administration for 7 days. According to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2018), the patients were given antihypertensive, hypoglycemic, lipid-lowering, anticoagulant or mannitol. All subjects were not allowed to receive interventional therapy (mechanical thrombectomy or stent implantation, etc.), thrombolysis (such as rtPA and urokinase), other cerebrovascular dilators (such as Butylphthalide, Flunarizine, Nicardipine and Nimodipine, etc.), other neuroprotective agents (such as Edaravone,etc., except citicoline) during the whole trial period. After the end of the treatment period (the 7th day), the subjects will enter the follow-up period (the 8th-90th day).
During the follow-up period, subjects need to be followed up twice (30th day ± 3 days, 90th day ± 7 days).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test group (SPT-07A injection group)
SPT-07A injection
20mg (2), dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
Control group (placebo group)
placebo
2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
Interventions
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SPT-07A injection
20mg (2), dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
placebo
2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Suzhou Huyun New Drug Research and Development Co., Ltd
UNKNOWN
Shanghai Canming Pharmaceutical Technology Co., Ltd
UNKNOWN
Beijing Haijinge Pharmaceutical Technology Co., Ltd
UNKNOWN
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
UNKNOWN
Xiang Yang NO.1 People's Hospital
UNKNOWN
Xiangyang Central Hospital
OTHER
Wuhan NO. 4 hospital
UNKNOWN
The Affiliated Hospital of Xuzhou Medical University
OTHER
Xuzhou Central Hospital
OTHER
Yan'an University Xianyang hospital Co., Ltd
UNKNOWN
Hengshui People's Hospital
OTHER
Inner Mongolia Baogang Hospital
OTHER
Daqing oilfield general hospital
UNKNOWN
The Fourth Affiliated Hospital of Harbin Medical University
OTHER
The First Hospital of Jilin University
OTHER
Meihekou Central Hospital
UNKNOWN
Jiangsu Taizhou People's Hospital
OTHER
Tianjin People's Hospital
OTHER
Taizhou Hospital
OTHER
Zhejiang Taizhou hospital
UNKNOWN
The First Affiliated Hospital of Nanhua University
UNKNOWN
Jining Medical University
OTHER
Zhongshan Hospital Xiamen University
OTHER
Neijiang Second People's Hospital
UNKNOWN
Tancheng first people's Hospital
UNKNOWN
The Affiliated Hospital of Qingdao University
OTHER
Taian Central Hospital
UNKNOWN
Weihai Municipal Hospital
OTHER
Nanyang nanshai hospital
UNKNOWN
Dezhou People's Hospital
OTHER
The First Affiliated Hospital of Nanyang Medical College
UNKNOWN
Deyang People's Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
Qingdao Central Hospital
OTHER
Fukuang General Hospital of Liaoning health industry group
UNKNOWN
Xi'an Gaoxin Hospital
OTHER
Affiliated Hospital of Jiaxing University
OTHER
Fujian Zhangzhou hospital
UNKNOWN
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
Daqing people's Hospital
UNKNOWN
Hainan People's Hospital
OTHER
Qujing first people's Hospital
UNKNOWN
The Third Affiliated Hospital of Qiqihar Medical College
UNKNOWN
The First Affiliated Hospital of Hebei North University
OTHER
Linfen Central Hospital
UNKNOWN
Xuancheng people's hospital
UNKNOWN
The First Affiliated Hospital of Shihezi University Medical College
UNKNOWN
Guangzhou Red Cross Hospital
OTHER
People's Hospital of Wuhan University
UNKNOWN
Wuhan Central Hospital
OTHER
Jingzhou Central Hospital
OTHER
The Central Hospital of Huanggang
OTHER
Sinopharm Dongfeng General Hospital
UNKNOWN
Changjiang Shipping General Hospital
UNKNOWN
Yichang Central People's Hospital
OTHER
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
OTHER
Xiangtan Central Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Hu Bo
Professor
Principal Investigators
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Bo Hu, Dr. or PhD.
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Wuhan Union Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPT-07A
Identifier Type: -
Identifier Source: org_study_id
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