NCT05159947

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,112

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

December 7, 2021

Last Update Submit

April 26, 2023

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • Good outcome at 90 days

    proportion of subjects with a modified Rankin Scale (mRS) ≤ 1

    at day 90 (±7)

Secondary Outcomes (6)

  • proportion of subjects with a modified Rankin Scale (mRS) ≤ 2 at day 90(±7)

    at day 90(±7)

  • National Institute of Health stroke scale (NIHSS) at day 8(+1)

    at day 8(+1)

  • Barthel Index (BI) at day 90(±7)

    at day 90(±7)

  • modified Rankin Scale (mRS) at day 8(+1), 30(±3) and day 90(±7)

    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)

    at day 8(+1), 30(±3) and day 90(±7)

  • +1 more secondary outcomes

Study Arms (2)

Test group (SPT-07A injection group)

EXPERIMENTAL
Drug: SPT-07A injection

Control group (placebo group)

PLACEBO COMPARATOR
Other: placebo

Interventions

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.

Test group (SPT-07A injection group)
placeboOTHER

2 Injection simulants, dissolved in 250ml of normal saline, and injected intravenously for 90±20min, twice a day, and administered for 7 days.

Control group (placebo group)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bo Hu, Dr. or PhD.

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wan, Dr.

CONTACT

+86-15872394527wanyanalan@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 16, 2021

Study Start

January 20, 2022

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)