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The primary purpose of this study is to evaluate the efficacy and safety of Baricitinib combined with endovascular therapy in patients with acute anterior circulation large vessel occlusion, to address futile recanalization with priority, and to elucidating the mechanism of JAK/STAT pathway inhibition on neuroprotection and inflammatory regulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2mg Baricitinib group+Guideline-based therapy | Experimental | One 2mg Baricitinib tablet and one 2mg placebo tablet are given once daily for 5 to 7 days. |
|
| Baricitinib 4mg group+Guideline-based therapy | Experimental | Two 2mg Baricitinib tablets are given three once daily for 5 to 7 days. |
|
| Sham group+Guideline-based therapy | Active Comparator | Two 2mg placebo tablets are given three times a day once daily for 5 to 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2mg Baricitinib | Drug | One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of 90-day mRS scores | The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death. | 90±14 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with functional independence outcome (mRS 0-2) at 90-day | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death). | 90±14 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Hu, MD, PhD | Contact | +86 055162284313 | andinghu@ustc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China, Hefei, Recruiting | Hefei | Anhui | 230001 | China |
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| 4mg Baricitinib | Drug | Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days. |
|
| Placebo | Drug | Two 2mg placebo tablets are given three times a day, last for 5±2 days. |
|
| Guideline-based therapy | Other | Guideline-based therapy including EVT treatment is determined by the physician. |
|
| Proportion of patients with functional independence outcome (mRS 0-1) at 90-day | modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death). | 90±14 days post-procedure |
| Change in NIHSS score at 5-7 days post-procedure | 5-7 days post-procedure |
| Any mortality at 90±14 days | Primary Safety Endpoints | 90±14 days post-procedure |
| Any symptomatic intracranial hemorrhage within 48h | Secondary Safety Endpoints | 48 hours post-procedure |
| Any asymptomatic intracranial hemorrhage within 48h | Secondary Safety Endpoints | 48 hours post-procedure |
| Any adverse event | Asymptomatic intracranial hemorrhage | 90±14 days post-procedure |
| ID | Term |
|---|---|
| D020243 | Infarction, Anterior Cerebral Artery |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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