Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction
NCT07721545, Phase 2, Phase 3, Not yet recruiting, Neurodawn Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction | ClinicalTrials.gov |
| NCT number | NCT07721545 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 944 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Neurodawn Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Perforating Artery Infarction, PAI | ClinicalTrials.gov |
| Interventions | Y-6 tablet, Placebo | ClinicalTrials.gov |
| First posted | 2026-07-23 | ClinicalTrials.gov |
| Last updated | 2026-07-23 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants achieving a modified Rankin Scale (mRS) score ≤1 after treatment | Day 90(+7 days) | The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability. | ClinicalTrials.gov |
| Secondary | Distribution of mRS scores after treatment | Day 90(+7 days) | The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability. | ClinicalTrials.gov |
| Secondary | Proportion of participants with stroke-related disability after treatment | Day90 (+7 days) | Stroke disability is defined as disability (modified Rankin Scale \[mRS\] score of 3-5), major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and vascular death, and all-cause mortality. | ClinicalTrials.gov |
| Secondary | Change from baseline in NIHSS (National Institutes of Health Stroke Scale) scores at each assessment time point | Day90 (+7 days) | The NIHSS total score ranges from 0 to 42, with higher scores indicating worse neurological outcomes. | ClinicalTrials.gov |
| Secondary | Proportion of participants achieving a Barthel Index score ≥95 after treatment | Day 90 (+7 days) | The Barthel Index (BI) is a measure of activities of daily living, with scores ranging from 0 to 100. Higher scores indicate greater independence, while lower scores indicate greater dependence on assistance for daily activities. | ClinicalTrials.gov |
| Secondary | Proportion of participants with early neurological deterioration after treatment | 72 hours (±12 hours) after treatment、Day 7 (±1 day) | Early neurological deterioration means within 7 days after stroke attack, an increase in NIHSS of ≥2 points or an increase in hemiparesis of ≥1 point or an increase in impaired consciousness of ≥1 point from baseline and excluding progression of disease due to intracranial hemorrhage by examination of cranial CT or MRI and exacerbation of disease due to other non-stroke causes, such as cardiac insufficiency, hepatic insufficiency, renal insufficiency, etc. | ClinicalTrials.gov |
| Secondary | Proportion of participants with ischemic stroke after treatment | Day90 (+7 days) | ClinicalTrials.gov | |
| Secondary | Incidence of moderate and severe bleeding events after treatment | Day 30 (±3 days)、Day 90 (+7 days) | Bleeding events will be classified according to the GUSTO bleeding criteria. Severe or life-threatening bleeding is defined as intracerebral hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment. Moderate bleeding is defined as bleeding requiring blood transfusion. Minor bleeding is defined as other bleeding events not requiring transfusion or causing hemodynamic compromise. | ClinicalTrials.gov |
| Secondary | Incidence of intracranial hemorrhage after treatment | Day 30 (±3 days)、Day 90 (+7 days) | ClinicalTrials.gov | |
| Secondary | Incidence of any bleeding events after treatment | Day 30 (±3 days)、Day 90 (+7 days) | ClinicalTrials.gov | |
| Secondary | All-cause Mortality after treatment | Day 30 (±3 days)、Day 90 (+7 days) | ClinicalTrials.gov | |
| Secondary | Incidence of platelet count ≤100 × 10⁹/L after treatment | Day 30 (±3 days）、Day 90(+7 days） | ClinicalTrials.gov | |
| Secondary | Incidence of new-onset moderate-to-severe headache after treatment | Day 30 (±3 days)、Day 90 (+7 days) | Headache severity will be assessed using the 11-point Numerical Rating Scale (11-NRS). The scale ranging from 0 to 10, where 0 indicates no headache and 10 indicates the worst imaginable headache. Higher scores indicate greater headache severity. | ClinicalTrials.gov |
| Secondary | Incidence and severity of adverse events after treatment | Day 90 (+7days) | ClinicalTrials.gov | |
| Secondary | The Incidence of subject getting abnormal results of physical examinations after treatment | Day 90 (+7days) | ClinicalTrials.gov | |
| Secondary | The Incidence of subject getting abnormal results of vital signs after treatment | Day 90 (+7days) | ClinicalTrials.gov | |
| Secondary | The Incidence of subject getting abnormal results of laboratory tests after treatment | Day 90 (+7days) | ClinicalTrials.gov | |
| Secondary | The Incidence of subject getting abnormal results of 12-lead electrocardiograms after treatment | Day 90 (+7 days) | ClinicalTrials.gov | |
| Other | Distribution of mRS scores after treatment | Day 180 (±10 days)、Day 360 (±15 days) | The scale ranges from 0 to 6, where a score of 0 indicates no symptoms and a score of 6 indicates death. Higher mRS scores represent greater disability. | ClinicalTrials.gov |
| Other | Proportion of participants with stroke-related disability after treatment | Day 180 (±10 days)、Day 360 (±15 days) | Stroke disability is defined as disability (modified Rankin Scale \[mRS\] score of 3-5), major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and vascular death, and all-cause mortality. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Other outcome | ConductCognition |
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Verbal Learning | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)