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

Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Trial of the Efficacy and Safety of SPT-07A Injection in Patients With Acute Ischemic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Drug: SPT-07A injection; Other: placebo

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: Interventional
• Enrollment (Anticipated): 1112
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yan Wan, Dr.; Phone Number: +86-15872394527; Email: wanyanalan@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Wuhan Union Hospital
      • Contact: Yan Wan, Dr.; Phone Number: +86-15872394527; Email: wanyanalan@163.com
      • Principal Investigator: Bo Hu, Dr./PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Good outcome at 90 days	proportion of subjects with a modified Rankin Scale (mRS) ≤ 1	at day 90 (±7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of subjects with a modified Rankin Scale (mRS) ≤ 2 at day 90(±7)	proportion of subjects with a modified Rankin Scale (mRS) ≤ 2	at day 90(±7)
National Institute of Health stroke scale (NIHSS) at day 8(+1)	proportion of subjects with a National Institute of Health stroke scale (NIHSS) 0-1 or mean improvement value from baseline	at day 8(+1)
Barthel Index (BI) at day 90(±7)	proportion of subjects with a Barthel Index (BI) ≥95	at day 90(±7)
modified Rankin Scale (mRS) at day 8(+1), 30(±3) and day 90(±7)	score of modified Rankin Scale (mRS)	at day 8(+1), 30(±3) and day 90(±7)
National Institute of Health stroke scale (NIHSS) at day 8(+1), 30(±3) and day 90(±7)	score of National Institute of Health stroke scale (NIHSS)	at day 8(+1), 30(±3) and day 90(±7)
Barthel Index (BI) at day 8(+1), 30(±3) and day 90(±7)	score of Barthel Index (BI)	at day 8(+1), 30(±3) and day 90(±7)

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: Zhongshan Hospital Xiamen University; The Affiliated Hospital of Qingdao University; The First Hospital of Jilin University; Xuzhou Central Hospital; Qingdao Central Hospital; The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Inner Mongolia Medical University; Taizhou Hospital; Yichang Central People's Hospital; Yantai Yuhuangding Hospital; Wuhan Central Hospital; Hainan People's Hospital; Tianjin People's Hospital; Guangzhou Red Cross Hospital; Xi'an Gaoxin Hospital; Weihai Municipal Hospital; Jiangsu Taizhou People's Hospital; The Fourth Affiliated Hospital of Harbin Medical University; The First Affiliated Hospital of Hebei North University; Dezhou People's Hospital; Fukuang General Hospital of Liaoning health industry group; Xiangyang Central Hospital; Xuancheng people's hospital; Xiangtan Central Hospital; Jingzhou Central Hospital; The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture; Huanggang Central Hospital; Inner Mongolia Baogang Hospital; Affiliated hospital of jining medical college; Deyang People's Hospital; 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; Wuhan NO. 4 hospital; Yan'an University Xianyang hospital Co., Ltd; Hengshui People's Hospital; Daqing oilfield general hospital; Meihekou Central Hospital; Zhejiang Taizhou hospital; The First Affiliated Hospital of Nanhua University; Neijiang Second People's Hospital; Tancheng first people's Hospital; Taian Central Hospital; Nanyang nanshai hospital; The First Affiliated Hospital of Nanyang Medical College; Fujian Zhangzhou hospital; Daqing people's Hospital; Qujing first people's Hospital; The Third Affiliated Hospital of Qiqihar Medical College; Linfen Central Hospital; The First Affiliated Hospital of Shihezi University Medical College; People's Hospital of Wuhan University; Sinopharm Dongfeng General Hospital; Changjiang Shipping General Hospital; Affiliated Hospital of Jiaxing University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Anticipated): January 10, 2024
• Study Completion (Anticipated): January 10, 2024

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: SPT-07A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No