Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke

Launched by BEIJING TIANTAN HOSPITAL · Jun 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called Y-6, given as a tablet placed under the tongue, to help people who have had a certain type of stroke called an acute ischemic stroke caused by a blockage in a large brain artery. The goal is to see if Y-6 can improve blood flow in small vessels and reduce inflammation after patients receive a common treatment called endovascular therapy, which helps open blocked arteries. The study will also check if Y-6 is safe to use in these patients.

To join the study, patients need to be between 35 and 80 years old and have had this type of stroke within the past 24 hours. They should be getting endovascular therapy and have no serious health issues like bleeding in the brain or severe organ problems. During the 3-month study, participants will have several check-ups to monitor their recovery and any side effects. The main goal is to see how well patients recover their ability to function 90 days after starting treatment, using a standard recovery scale. This study is not yet recruiting, but it hopes to find a new way to protect the brain and improve outcomes after stroke treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 35 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;
• • 6\<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.
• Exclusion Criteria:
• • 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;
• • Patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs;
• • Patients with life expectancy of less than 3 months;
• • Patients who have received treatment of investigational drugs or devices within previous 3 months;
• • Other investigator-evaluated conditions which may influence the compliance of patients or where it is not suitable for patients to participate in this trial.