Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke

NCT07040085 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: YW2025-020-01
• Study Type: interventional
• Target: 892
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy of Y-6 sublingual tablets in improving microcirculation dysfunction and reducing thrombo-inflammation in patients who had AIS caused by LVO and will receive EVT. Moreover, we expect to evaluate the safety of using Y-6 sublingual tablet in such study population. This study rationale is based on the following scheme: in patients with acute ischemic stroke caused by LVO, receiving reperfusion therapy may cause futile recanalization and thus lead to microcirculation dysfunction and thrombo-inflammation as consequences. Dexborneol has anti-inflammatory effects and Cilostazol has antiplatelet effects and BBB protection; therefore, the multi-component tablet may exert neuroprotective effects in terms of improving microcirculation dysfunction and reducing thrombo-inflammation in patients with AIS after reperfusion therapy. The primary purpose of this study is to investigate the proportion of modified-Rankin scale (mRS) score recovered to 0\~1 score at 90 days after randomization. The follow-up duration is 3 months, and the visit schedule is as follows: Subjects enrolled based on randomization procedures will receive visits at screening/baseline period, 1 day, 7 days, 28 days and 90 days after randomization, and in case of any events.

Conditions

Stroke

Keywords

Y-6; stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization.

  mRS recover to 0-1

  90 days

Secondary Outcomes (4)

• •mRS at 90 days after randomization

  90 days

• • Changes in NIHSS from baseline to 1 day, 7 days and 28 days after randomization；

  from baseline to 1 day, 7 days and 28 days

• • Proportion of patients with early neurological deterioration at 1 day after randomization;

  at 1 day

• • Proportion of subjects with combined vascular events at 90 days after randomization.

  90 days

Other Outcomes (9)

• • Incidence and severity of treatment emergent adverse events (TEAEs) across treatment groups

  During the 90 days

• • Changes in laboratory test results after treatment;

  During the 90 days

• • Changes in vital signs after treatment

  During the 90 days

Study Arms (2)

Y-6

EXPERIMENTAL

Take the Y-6 sublingual tablet (each tablet contains 6 mg Dexborneol and 25 mg Cilostazol ), for 28 days continuously.

Drug: Y-6

Y-6 placebo

PLACEBO COMPARATOR

Take the placebo of Y-6 sublingual tablet (each tablet contains 0.06 mg Dexborneol and 0 mg Cilostazol ), for 28 days continuously.

Drug: Y-6 placebo

Interventions

Y-6 DRUG

each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days.

Y-6

Y-6 placebo DRUG

each tablet of Y-6 placebo contained 0.06 mg of dexborneol and 0 mg of cilostazol. Both groups took one tablet q12h for 28 days.

Y-6 placebo

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ Age ≤ 80 years old;
• Patients with acute ischemic stroke diagnosed within 24 hours of onset (time from onset to start of endovascular treatment);
• Patients with first stroke or mRS score 0-1 prior to this onset ;
• Patients with acute intracranial large vessel occlusion (LVO) confirmed by imaging examination, including occlusion of intracranial segments of internal carotid arteries, T-shaped bifurcation, MCA M1 and/or M2 segments and ACA A1 and/or A2 segments;
• ASPECTS score ≥ 6 at screening;
• \<NIHSS score ≤ 25 after this onset;
• Patients who had the indications for endovascular treatment and were scheduled for endovascular treatment;
• Patients or his/her legal representatives were able to understand and sign the informed consent.

You may not qualify if:

• Patients who are allergic to the active ingredients or excipients of investigational products；
• Severe disorder of consciousness at screening: NIHSS 1a consciousness level ≥2 points;
• Patients with previously diagnosed intracranial haemorrhage at screening, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.;
• Patients with previously diagnosed intracranial tumor, arteriovenous malformation, or aneurysm at screening;
• Patients with previously diagnosed congestive heart failure at screening;
• Patients with bilateral LVO at anterior circulation or LVO at posterior circulation or LVO of unknown aetiology at screening;
• Patients who have received treatment with warfarin, novel oral anticoagulants, argatroban, snake venom, defibrase, lumbrokinase and batroxobin after onset;
• Patients with severe hematologic abnormality or severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons at screening (hematologic abnormality was defined as platelet count \<100×109/L; severe hepatic insufficiency was defined as ALT \> 3 × ULN or AST \>3 × ULN; severe renal insufficiency was defined as serum creatinine \>3.0 mg/dl (265.2 μmol/L) or creatinine clearance \< 30 ml/min);
• Patients with previously diagnosed hemorrhagic tendency (including but not limited to): hemorrhagic retinopathy or hereditary hemorrhagic disorders, such as hemophilia, at screening;
• Patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg);
• Patients with history of major head trauma or stroke within 1 month prior to randomization;
• Patients who have received intracranial or spinal surgery within 3 months prior to randomization;
• Patients with history of major surgery or serious physical trauma within 1 month prior to randomization;
• Male subjects (or their mates) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period;
• Patients with contraindications to known contrast agents or other contrast agents;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Neurodawn Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yilong Wang, MD, PhD

CONTACT

010-59975025; yilong528@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI，chief physician

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 26, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share