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 : Not yet recruiting

First Posted : December 16, 2021

Last Update Posted : December 16, 2021

See Contacts and Locations

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke, Acute	Drug: SPT-07A injection Other: placebo	Phase 3

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1112 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Trial of the Efficacy and Safety of SPT-07A Injection in Patients With Acute Ischemic Stroke
Estimated Study Start Date :	December 2021
Estimated Primary Completion Date :	January 2022
Estimated Study Completion Date :	January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test group (SPT-07A injection group)	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.
Placebo Comparator: Control group (placebo group)	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.

Outcome Measures

Primary Outcome Measures :

Good outcome at 90 days [ Time Frame: at day 90 (±7) ]
proportion of subjects with a modified Rankin Scale (mRS) ≤ 1

Secondary Outcome Measures :

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)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females aged 18 to 85 years;
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;
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.
First onset of ischemic stroke or prestroke with mRS of 0 or 1;
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;
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:

Serious disturbance of consciousness (NIHSS 1a ≥2 score);
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;
Neuroimaging (CT/MRI) revealed intracranial hemorrhagic diseases (such as cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricular hemorrhage, traumatic cerebral hemorrhage, etc.);
Rapidly improving or resolving symptoms, suggesting a possible transient ischemic attack (TIA) rather than a qualifying stroke;
Subjects who are ready to undergo or have undergone intravenous thrombolysis, or endovascular therapy in 90 days from onset;
Renal insufficiency: Serum creatinine > 2.5 times the upper limit of normal value, or other known serious renal insufficiency diseases;
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.;
Poorly controlled hypertension, with systolic blood pressure (≥ 180 mmHg) and/or diastolic blood pressure ( ≥110 mmHg);
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);
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;
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;
Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant;
Allergic constitution, or allergic to experimental drugs, analogous drugs or basic treatment drugs;
Received treatment with any other investigational drug within 30 days before Baseline, or is currently participating in another clinical study;
Any other reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.

Contacts and Locations