NCT04950790

Brief Summary

This is a randomized, double-blind, placebo-parallel-controlled multiplier designed to observe and evaluate the efficacy and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days and continue follow-up to 90 days after the onset of the disease.

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
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

3.7 years

First QC Date

June 27, 2021

Last Update Submit

July 4, 2021

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (4)

  • mRS score

    Percentage of patients with mRS score ≤2 at 90 days post-onset.

    baseline

  • mRS score

    Percentage of patients with mRS score ≤2 at 90 days post-onset.

    10 days after treatment

  • mRS score

    Percentage of patients with mRS score ≤2 at 90 days post-onset.

    30 days after onset

  • mRS score

    Percentage of patients with mRS score ≤2 at 90 days post-onset.

    90 days after onset

Study Arms (2)

Test group

EXPERIMENTAL

Shuxuening injection + basic treatment

Drug: Shuxinin injectionDrug: Basic treatment

Control group

PLACEBO COMPARATOR

placebo (sterilized water for injection) + basic treatment

Drug: Basic treatmentDrug: Placebo

Interventions

Shuxinin injectionDRUG

Shuxuening injection : 5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.

Test group
Basic treatmentDRUG

Give oral aspirin enteric soluble tablets 150-300mg/d as early as possible after the onset of the disease, which can be changed to a prophylactic dose (50-325mg/d) after the acute phase. For those who cannot tolerate For those who cannot tolerate aspirin, clopidogrel can be used.

Control groupTest group
PlaceboDRUG

sterilized water for injection，5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.

Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meeting the diagnostic criteria for acute ischemic stroke;
  • Patients with complete anterior circulation infarction (TACI), partial anterior circulation infarction (PACI), lacunar infarction (LACI) in OCSP classification;
  • Patients within 72 hours after onset;
  • NIHSS score ≥4 points and ≤17 points;
  • Aged between 40 and 80 (including 40 and 80); 7) Signing the Informed Consent.

You may not qualify if:

  • intracranial hemorrhagic disease indicated by head CT or MRI, or disease with bleeding tendency;
  • Patients treated with vascular opening (such as thrombolysis, arterial thrombectomy, ultra-early thrombosis aspiration and stenting, etc.) after the onset of this disease;
  • Cerebral embolism caused by brain tumor, brain injury, brain parasitic disease, metabolic disorder, rheumatic heart disease and coronary heart disease confirmed by examination;
  • Patients with other diseases affecting limb mobility, such as claudication, osteoarthritis (active stage), rheumatoid arthritis (active stage), gouty arthritis and other limb mobility disorders that may affect neurological function examination;
  • Patients with post-treatment systolic blood pressure ≥180 mmHg or fasting blood glucose concentration \< 2.8mmol/L;
  • patients with severe heart and lung diseases and chronic liver and kidney dysfunction, including 1.5 times of the upper normal limit of liver function ALT and AST \> and 1.2 times of the upper normal limit of renal function serum creatinine (SCR) \>);
  • patients with complicated mental illness who are unable or unwilling to cooperate;
  • People with known allergies to the drug and its components (including excipients such as ethanol) and allergic constitution;
  • Patients enrolled in other clinical trials within 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Xiaogang Li

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaogang Li

CONTACT

13501095002xgangli2002@163.com

Dongsheng Fan

CONTACT

13701023871

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 6, 2021

Study Start

April 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)