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SPT-07A Injection in Patients With Acute Ischemic Stroke (AIS): A Phase III Clinical Trial (SPAIR-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05159947
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : September 29, 2022
Sponsor:
Collaborators:
Suzhou Huyun New Drug Research and Development Co., Ltd
Shanghai Canming Pharmaceutical Technology Co., Ltd
Beijing Haijinge Pharmaceutical Technology Co., Ltd
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Xiang Yang NO.1 People's Hospital
Xiangyang Central Hospital
Wuhan NO. 4 hospital
The Affiliated Hospital of Xuzhou Medical University
Xuzhou Central Hospital
Yan'an University Xianyang hospital Co., Ltd
Hengshui People's Hospital
Inner Mongolia Baogang Hospital
Daqing oilfield general hospital
The Fourth Affiliated Hospital of Harbin Medical University
The First Hospital of Jilin University
Meihekou Central Hospital
Jiangsu Taizhou People's Hospital
Tianjin People's Hospital
Taizhou Municipal Hospital
Zhejiang Taizhou hospital
The First Affiliated Hospital of Nanhua University
Affiliated hospital of jining medical college
Zhongshan Hospital Xiamen University
Neijiang Second People's Hospital
Tancheng first people's Hospital
The Affiliated Hospital of Qingdao University
Taian Central Hospital
Weihai Municipal Hospital
Nanyang nanshai hospital
Dezhou People's Hospital
The First Affiliated Hospital of Nanyang Medical College
Deyang People's Hospital
Yantai Yuhuangding Hospital
Qingdao Central Hospital
Fukuang General Hospital of Liaoning health industry group
Xi'an Gaoxin Hospital
Jiaxing First Hospital
Fujian Zhangzhou hospital
The Affiliated Hospital of Inner Mongolia Medical University
Daqing people's Hospital
Hainan People's Hospital
Qujing first people's Hospital
The Third Affiliated Hospital of Qiqihar Medical College
The First Affiliated Hospital of Hebei North University
Linfen Central Hospital
Xuancheng people's hospital
The First Affiliated Hospital of Shihezi University Medical College
Guangzhou Red Cross Hospital
People's Hospital of Wuhan University
Wuhan Central Hospital
Jingzhou Central Hospital
Huanggang Central Hospital
Sinopharm Dongfeng General Hospital
Changjiang Shipping General Hospital
Yichang Central People's Hospital
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Xiangtan Central Hospital
Information provided by (Responsible Party):
Hu Bo, Wuhan Union Hospital, China

Tracking Information
First Submitted Date  ICMJE December 7, 2021
First Posted Date  ICMJE December 16, 2021
Last Update Posted Date September 29, 2022
Actual Study Start Date  ICMJE January 20, 2022
Estimated Primary Completion Date January 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
Good outcome at 90 days [ Time Frame: at day 90 (±7) ]
proportion of subjects with a modified Rankin Scale (mRS) ≤ 1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2021)
  • proportion of subjects with a modified Rankin Scale (mRS) ≤ 2 at day 90(±7) [ Time Frame: at day 90(±7) ]
    proportion of subjects with a modified Rankin Scale (mRS) ≤ 2
  • National Institute of Health stroke scale (NIHSS) at day 8(+1) [ Time Frame: at day 8(+1) ]
    proportion of subjects with a National Institute of Health stroke scale (NIHSS) 0-1 or mean improvement value from baseline
  • Barthel Index (BI) at day 90(±7) [ Time Frame: at day 90(±7) ]
    proportion of subjects with a Barthel Index (BI) ≥95
  • modified Rankin Scale (mRS) at day 8(+1), 30(±3) and day 90(±7) [ Time Frame: at day 8(+1), 30(±3) and day 90(±7) ]
    score of modified Rankin Scale (mRS)
  • National Institute of Health stroke scale (NIHSS) at day 8(+1), 30(±3) and day 90(±7) [ Time Frame: at day 8(+1), 30(±3) and day 90(±7) ]
    score of National Institute of Health stroke scale (NIHSS)
  • Barthel Index (BI) at day 8(+1), 30(±3) and day 90(±7) [ Time Frame: at day 8(+1), 30(±3) and day 90(±7) ]
    score of Barthel Index (BI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPT-07A Injection in Patients With Acute Ischemic Stroke (AIS): A Phase III Clinical Trial
Official Title  ICMJE Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Trial of the Efficacy and Safety of SPT-07A Injection in Patients With Acute Ischemic Stroke
Brief 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.
Detailed Description

The target population of this study is patients with acute ischemic stroke within 48 hours. All potential participants must provide informed consent, and those who provide informed consent will enter the screening (- 48 ~ 0h), and the screening qualification will be evaluated according to the inclusion criteria. The eligible subjects will enter the treatment period (day 1-7) and will be randomly assigned to the experimental group (SPT-07A injection group) or the control group (placebo group).

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke, Acute
Intervention  ICMJE
  • Drug: 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.
  • Other: placebo
    2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
Study Arms  ICMJE
  • Experimental: Test group (SPT-07A injection group)
    Intervention: Drug: SPT-07A injection
  • Placebo Comparator: Control group (placebo group)
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 15, 2021)
1112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yan Wan, Dr. +86-15872394527 wanyanalan@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05159947
Other Study ID Numbers  ICMJE SPT-07A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Hu Bo, Wuhan Union Hospital, China
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Wuhan Union Hospital, China
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Suzhou Huyun New Drug Research and Development Co., Ltd
  • Shanghai Canming Pharmaceutical Technology Co., Ltd
  • Beijing Haijinge Pharmaceutical Technology Co., Ltd
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
  • Xiang Yang NO.1 People's Hospital
  • Xiangyang Central Hospital
  • Wuhan NO. 4 hospital
  • The Affiliated Hospital of Xuzhou Medical University
  • Xuzhou Central Hospital
  • Yan'an University Xianyang hospital Co., Ltd
  • Hengshui People's Hospital
  • Inner Mongolia Baogang Hospital
  • Daqing oilfield general hospital
  • The Fourth Affiliated Hospital of Harbin Medical University
  • The First Hospital of Jilin University
  • Meihekou Central Hospital
  • Jiangsu Taizhou People's Hospital
  • Tianjin People's Hospital
  • Taizhou Municipal Hospital
  • Zhejiang Taizhou hospital
  • The First Affiliated Hospital of Nanhua University
  • Affiliated hospital of jining medical college
  • Zhongshan Hospital Xiamen University
  • Neijiang Second People's Hospital
  • Tancheng first people's Hospital
  • The Affiliated Hospital of Qingdao University
  • Taian Central Hospital
  • Weihai Municipal Hospital
  • Nanyang nanshai hospital
  • Dezhou People's Hospital
  • The First Affiliated Hospital of Nanyang Medical College
  • Deyang People's Hospital
  • Yantai Yuhuangding Hospital
  • Qingdao Central Hospital
  • Fukuang General Hospital of Liaoning health industry group
  • Xi'an Gaoxin Hospital
  • Jiaxing First Hospital
  • Fujian Zhangzhou hospital
  • The Affiliated Hospital of Inner Mongolia Medical University
  • Daqing people's Hospital
  • Hainan People's Hospital
  • Qujing first people's Hospital
  • The Third Affiliated Hospital of Qiqihar Medical College
  • The First Affiliated Hospital of Hebei North University
  • Linfen Central Hospital
  • Xuancheng people's hospital
  • The First Affiliated Hospital of Shihezi University Medical College
  • Guangzhou Red Cross Hospital
  • People's Hospital of Wuhan University
  • Wuhan Central Hospital
  • Jingzhou Central Hospital
  • Huanggang Central Hospital
  • Sinopharm Dongfeng General Hospital
  • Changjiang Shipping General Hospital
  • Yichang Central People's Hospital
  • Enshi Tujia and Miao Autonomous Prefecture Central Hospital
  • Xiangtan Central Hospital
Investigators  ICMJE
Principal Investigator: Bo Hu, Dr. or PhD. Wuhan Union Hospital, China
PRS Account Wuhan Union Hospital, China
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP