Stroke, AcutePhase 3SPAIR-2NCT05159947
SPT-07A Injection in Patients With Acute Ischemic Stroke (AIS): A Phase III Clinical Trial
A Phase 3 study testing SPT-07A injection in people with Stroke, Acute, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- SPT-07A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,112 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2022to 10 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Yan Wan, Dr., +86-15872394527, wanyanalan@163.com
Bo Hu, Dr./PhD.
About this study
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
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.
Read the 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).
- Conditions
- Stroke, Acute
- Being tested
- SPT-07A injection, placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPT-07A injectionDrug
20mg (2), dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
placeboOther
2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Test group (SPT-07A injection group) | Experimental | Not described Receives: Drug: SPT-07A injection |
| Control group (placebo group) | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good outcome at 90 days
proportion of subjects with a modified Rankin Scale (mRS) ≤ 1
Measured: at day 90 (±7)
Secondary outcomes (6)
proportion of subjects with a modified Rankin Scale (mRS) ≤ 2 at day 90(±7)
proportion of subjects with a modified Rankin Scale (mRS) ≤ 2
Measured: 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
Measured: at day 8(+1)
Barthel Index (BI) at day 90(±7)
proportion of subjects with a Barthel Index (BI) ≥95
Measured: at day 90(±7)
modified Rankin Scale (mRS) at day 8(+1), 30(±3) and day 90(±7)
score of modified Rankin Scale (mRS)
Measured: 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)
Measured: 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)
Measured: at day 8(+1), 30(±3) and day 90(±7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start20 Jan 2022
- Primary completion10 Jan 2024 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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, Xiangyang 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 Oil Field 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 Hospital, Zhejiang Taizhou hospital, The First Affiliated Hospital of Nanhua University, Affiliated Hospital of Jining Medical University, Zhongshan Hospital Xiamen University, Neijiang Second People's Hospital, Tancheng first people's Hospital, The Affiliated Hospital of Qingdao University, Taian City Central Hospital, Weihai Municipal Hospital, Nanyang Nanshi Hospital, Dezhou People's Hospital, 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, Affiliated Hospital of Jiaxing University, Fujian Zhangzhou hospital, The Affiliated Hospital of Inner Mongolia Medical University, Daqing Longnan 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, Guangzhou Red Cross Hospital, People's Hospital of Wuhan University, Wuhan Central Hospital, Jingzhou Central Hospital, The Central Hospital of Huanggang, Sinopharm Dongfeng General Hospital, Changjiang Shipping General Hospital, Yichang Central People's Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangtan Central Hospital
- Responsible party
- Principal investigator, Hu Bo, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Bo Hu, Dr. or PhD., Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159947
- Sponsor's protocol ID
- SPT-07A
- Acronym
- SPAIR-2
- Status last verified
- Apr 2023
- First submitted
- 7 Dec 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05159947
- Acronym / sponsor ID
- SPAIR-2 / SPT-07A
- Conditions
- Stroke, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,112 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- 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, Xiangyang 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 Oil Field 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 Hospital, Zhejiang Taizhou hospital, The First Affiliated Hospital of Nanhua University, Affiliated Hospital of Jining Medical University, Zhongshan Hospital Xiamen University, Neijiang Second People's Hospital, Tancheng first people's Hospital, The Affiliated Hospital of Qingdao University, Taian City Central Hospital, Weihai Municipal Hospital, Nanyang Nanshi Hospital, Dezhou People's Hospital, 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, Affiliated Hospital of Jiaxing University, Fujian Zhangzhou hospital, The Affiliated Hospital of Inner Mongolia Medical University, Daqing Longnan 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, Guangzhou Red Cross Hospital, People's Hospital of Wuhan University, Wuhan Central Hospital, Jingzhou Central Hospital, The Central Hospital of Huanggang, Sinopharm Dongfeng General Hospital, Changjiang Shipping General Hospital, Yichang Central People's Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangtan Central Hospital
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (SPT-07A injection group) | Experimental | Drug: SPT-07A injection |
| Control group (placebo group) | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPT-07A injection20mg (2), dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days. | Drug | Test group (SPT-07A injection group) |
| placebo2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days. | Other | Control group (placebo group) |
Primary outcome
Good outcome at 90 days
Time frame: at day 90 (±7)
proportion of subjects with a modified Rankin Scale (mRS) ≤ 1
6 secondary outcomes
proportion of subjects with a modified Rankin Scale (mRS) ≤ 2 at day 90(±7)
Time frame: at day 90(±7)
National Institute of Health stroke scale (NIHSS) at day 8(+1)
Time frame: at day 8(+1)
Barthel Index (BI) at day 90(±7)
Time frame: at day 90(±7)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Hu, Dr. or PhD. principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPT-07A injection in people with Stroke, Acute, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wan, Dr. (+86-15872394527, wanyanalan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good outcome at 90 days (time frame: at day 90 (±7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.