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Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke

NCT04950920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 914

Last updated 2023-08-22

No results posted yet for this study

Summary

At present, the treatment of acute ischemic stroke includes intravenous thrombolysis, intravascular interventional therapy (including arterial thrombolysis, mechanical thrombectomy, angioplasty and stent implantation), antiplatelet therapy, anticoagulant therapy, defibrasion therapy, volume expansion therapy, and neuroprotective therapy. Y-2 sublingual tablet is an innovative drug developed by Yantai yinuoyi Biomedical Technology Co., Ltd. with independent intellectual property rights. This product is a free radical scavenger and inflammatory protein expression inhibitor. It can clear hydroxyl free radical (COH), nitric oxide free radical (no) and peroxynitrite ion (onoa), and inhibit the expression of tumor necrosis factor-A (TNF-a), interleukin IP (IL-1 (3), cyclooxygenase-2 (COX-2) and inducible nitric oxide synthase (iNOS) and other inflammatory related proteins induced by cerebral ischemia. By clearing the excessive free radicals produced in the brain tissue during ischemia and reperfusion and inhibiting the secondary inflammatory reaction, we can reduce the damage of free radicals and inflammatory reaction to the brain tissue, block the pathological change process caused by cerebral ischemia from two ways, and play a synergistic therapeutic role in cerebral ischemia injury.

Conditions

Interventions

DRUG

Y-2 sublingual tablets

30mg Edaravone+6mg d-borneo OR， Bid

DRUG

d-borneol

60 μg d-borneol OR， Bid

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Dongsheng Fan, PhD · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2022-08-10
Completion
2022-11-14

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950920 on ClinicalTrials.gov