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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Shuxinin injection; Drug: Basic treatment; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaogang Li; Phone Number: 13501095002; Email: xgangli2002@163.com
• Study Contact Backup: Name: Dongsheng Fan; Phone Number: 13701023871

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Xiaogang Li; Phone Number: 13501095002; Email: xgangli2002@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. meeting the diagnostic criteria for acute ischemic stroke;
2. Patients with complete anterior circulation infarction (TACI), partial anterior circulation infarction (PACI), lacunar infarction (LACI) in OCSP classification;
3. Patients within 72 hours after onset;
4. NIHSS score ≥4 points and ≤17 points;
5. The modified Rankin Scale (MRS) score was between 0 and 1, and the MRS score before inclusion was > 2;
6. Aged between 40 and 80 (including 40 and 80); 7) Signing the Informed Consent.

Exclusion Criteria:

1. intracranial hemorrhagic disease indicated by head CT or MRI, or disease with bleeding tendency;
2. Patients treated with vascular opening (such as thrombolysis, arterial thrombectomy, ultra-early thrombosis aspiration and stenting, etc.) after the onset of this disease;
3. Cerebral embolism caused by brain tumor, brain injury, brain parasitic disease, metabolic disorder, rheumatic heart disease and coronary heart disease confirmed by examination;
4. 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;
5. Patients with post-treatment systolic blood pressure ≥180 mmHg or fasting blood glucose concentration < 2.8mmol/L;
6. 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) >);
7. patients with complicated mental illness who are unable or unwilling to cooperate;
8. People with known allergies to the drug and its components (including excipients such as ethanol) and allergic constitution;
9. Any other patients considered by the investigator to be unsuitable for inclusion or to be affected by factors affecting study participation or completion;
10. Patients enrolled in other clinical trials within 1 month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test group; Shuxuening injection + basic treatment	Drug: Shuxinin injection; Shuxuening injection : 5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.; Drug: Basic treatment; 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.
PLACEBO_COMPARATOR: Control group; placebo (sterilized water for injection) + basic treatment	Drug: Basic treatment; 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.; Drug: Placebo; sterilized water for injection，5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Handan Central Hospital
• Investigators: Principal Investigator: Xiaogang Li, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (ACTUAL): July 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: D2018041

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