StrokePhase 3NCT07040085
Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke
A Phase 3 study testing Y-6 in people with Stroke, run by Beijing Tiantan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Y-6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 892 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke: a Randomised, Double-blind, Multicenter, Placebo-controlled Phase 3 Trial (FUTURE-2)
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.
Read more
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
- Being tested
- Y-6, Y-6 placebo
- Keywords
- Y-6, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-6Drug
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 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Y-6 | Experimental | Take the Y-6 sublingual tablet (each tablet contains 6 mg Dexborneol and 25 mg Cilostazol ), for 28 days continuously. Receives: 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. Receives: Drug: Y-6 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization.
mRS recover to 0-1
Measured: 90 days
Secondary outcomes (4)
•mRS at 90 days after randomization
mRS (0-6); the scale ranges from 0 to 5, where 0 indicates no symptoms, and 5 signifies severe disability requiring continuous care and assistance. 6, denotes death.
Measured: 90 days
• Changes in NIHSS from baseline to 1 day, 7 days and 28 days after randomization；
Changes in NIHSS; the total score ranges from 0 to 42, with lower scores indicating better neurological status.
Measured: from baseline to 1 day, 7 days and 28 days
• Proportion of patients with early neurological deterioration at 1 day after randomization;
early neurological deterioration
Measured: at 1 day
• Proportion of subjects with combined vascular events at 90 days after randomization.
combined vascular events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start5 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 892 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neurodawn Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040085
- Sponsor's protocol ID
- YW2025-020-01
- Status last verified
- May 2025
- First submitted
- 10 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke: a Randomised, Double-blind, Multicenter, Placebo-controlled Phase 3 Trial (FUTURE-2)
- ClinicalTrials.gov ID
- NCT07040085
- Acronym / sponsor ID
- YW2025-020-01
- Conditions
- Stroke
- Keywords
- Y-6, stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 892 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Neurodawn Pharmaceutical Co., Ltd.
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-6 | Experimental | Drug: Y-6Take the Y-6 sublingual tablet (each tablet contains 6 mg Dexborneol and 25 mg Cilostazol ), for 28 days continuously. |
| Y-6 placebo | Placebo comparator | Drug: Y-6 placeboTake the placebo of Y-6 sublingual tablet (each tablet contains 0.06 mg Dexborneol and 0 mg Cilostazol ), for 28 days continuously. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-6each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days. | Drug | Y-6 |
| Y-6 placeboeach 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. | Drug | Y-6 placebo |
Primary outcome
Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization.
Time frame: 90 days
mRS recover to 0-1
4 secondary outcomes
•mRS at 90 days after randomization
Time frame: 90 days
• Changes in NIHSS from baseline to 1 day, 7 days and 28 days after randomization；
Time frame: from baseline to 1 day, 7 days and 28 days
• Proportion of patients with early neurological deterioration at 1 day after randomization;
Time frame: at 1 day
• Proportion of subjects with combined vascular events at 90 days after randomization.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Y-6 in people with Stroke, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilong Wang, MD, PhD (010-59975025, yilong528@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.