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Study on the Effectiveness and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Shuxinin injection

Basic treatment

Placebo

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;
The modified Rankin Scale (MRS) score was between 0 and 1, and the MRS score before inclusion was > 2;
Aged between 40 and 80 (including 40 and 80); 7) Signing the Informed Consent.

Exclusion Criteria:

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;
Any other patients considered by the investigator to be unsuitable for inclusion or to be affected by factors affecting study participation or completion;
Patients enrolled in other clinical trials within 1 month.

Sites / Locations

Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Control group

Arm Description

Shuxuening injection + basic treatment

placebo (sterilized water for injection) + basic treatment

Outcomes

Primary Outcome Measures

mRS score

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

mRS score

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

mRS score

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

mRS score

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04950790

First Posted

June 27, 2021

Last Updated

July 4, 2021

Sponsor

Peking University Third Hospital

Collaborators

Handan Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04950790

Brief Title

Study on the Effectiveness and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

Official Title

A Randomized, Double-blind, Placebo-parallel-controlled, Multicenter Clinical Trial of the Efficacy and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University Third Hospital

Collaborators

Handan Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Cerebral infarction (CI), also known as ischemic stroke, refers to the softening and necrosis of local brain tissue due to blood circulation disorders, ischemia, and hypoxia. According to the 2016 Stroke Epidemiology Report [4], there are currently 70 million stroke patients in my country, 2 million new strokes occur each year, and 1.65 million deaths due to stroke each year. There is one Chinese every 12 seconds. Stroke occurs, and one Chinese person dies of a stroke every 21 seconds. Chinese people who die from a stroke each year account for 22.45% of all deaths. According to the results of the study on the incidence and mortality of stroke in the Chinese population, stroke is currently the number one cause of death in China, accounting for 20% of deaths in urban populations and 19% in rural areas. Cerebral infarction is a disease with high morbidity, high disability, high mortality and high recurrence rate in China, and it has gradually attracted widespread attention from the whole society. Shuxuening injection is developed by Shiyao Yinhu Pharmaceutical Co., Ltd., and is a sterile aqueous solution made of ginkgo biloba or ginkgo biloba extract. The auxiliary materials are ethanol and vitamin C. Its main function is to expand blood vessels and improve microcirculation. It is used for ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, cerebral embolism, cerebral vasospasm, etc. This trial is a randomized, double-blind, placebo-controlled multicenter clinical trial. The aim was to observe the effectiveness and safety of Shuxuening injection in the treatment of acute ischemic stroke for 10 days, and to continue follow-up to 90 days after the onset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

Shuxuening injection + basic treatment

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

placebo (sterilized water for injection) + basic treatment

Intervention Type

Drug

Intervention Name(s)

Shuxinin injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Basic treatment

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

mRS score

Description

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

Time Frame

baseline

Title

mRS score

Description

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

Time Frame

10 days after treatment

Title

mRS score

Description

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

Time Frame

30 days after onset

Title

mRS score

Description

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

Time Frame

90 days after onset

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; The modified Rankin Scale (MRS) score was between 0 and 1, and the MRS score before inclusion was > 2; Aged between 40 and 80 (including 40 and 80); 7) Signing the Informed Consent. Exclusion Criteria: 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; Any other patients considered by the investigator to be unsuitable for inclusion or to be affected by factors affecting study participation or completion; Patients enrolled in other clinical trials within 1 month.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaogang Li

Phone

13501095002

xgangli2002@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dongsheng Fan

Phone

13701023871

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaogang Li

Organizational Affiliation

Peking University Third Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Third Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaogang Li

Phone

13501095002

xgangli2002@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study on the Effectiveness and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

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