Acute Ichemic Stroke, Anterior Cerebral Artery Stroke, Baricitinib
Conditions
Brief summary
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.
Interventions
DRUG2mg Baricitinib
One 2mg Baricitinib tablet and one 2mg placebo tablet are given three times a day, last for 5±2 days.
DRUG4mg Baricitinib
Two 2mg Baricitinib tablets are given three times a day, last for 5±2 days.
DRUGPlacebo
Two 2mg placebo tablets are given three times a day, last for 5±2 days.
Guideline-based therapy including EVT treatment is determined by the physician.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age is 18 years old or above. 2. Diagnosed as anterior circulation large vessel occlusion stroke by CTA, MRA or DSA. 3. Randomized within 24h after the onset. 4. The NIHSS score is above 5 and the ASPECT score is above 3 points while receiving imaging examination; 5. The mTICI score after endovascular treatment (EVT) is above 2b. 6. informed consent.
Exclusion criteria
1. Intracranial hemorrhage confirmed by CT or MRI. 2. mRS score\>2 for patients \<80 years, or mRS score\>1 for those ≥80 years before onset. 3. Pregnant or lactating women. 4. Allergic to contrast agents. 5. Allergic to baricitinib or having contraindications for using baricitinib. 6. Participating in other clinical studies. 7. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, and unable to be controlled by oral antihypertensive drugs. 8. Genetic or acquired bleeding diathesis, lack of anticoagulant factors or having taken oral anticoagulants and INR \>1.7. 9. Hemoglobin value \<8g/L. 10. Recent history of using other JAK inhibitors or potent immunosuppressants, including but not limited to the combined use with potent immunosuppressive drugs such as azathioprine, tacrolimus, tofacitinib and fedratinib, etc. Tortuous arteries make the thrombectomy device unable to reach the target blood vessel. 11. Previous history of diagnosed viral hepatitis and tuberculosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of 90-day mRS scores | 90±14 days post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with functional independence outcome (mRS 0-2) at 90-day | 90±14 days post-procedure | 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). |
| Proportion of patients with functional independence outcome (mRS 0-1) at 90-day | 90±14 days post-procedure | 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). |
| Change in NIHSS score at 5-7 days post-procedure | 5-7 days post-procedure | — |
| Any mortality at 90±14 days | 90±14 days post-procedure | Primary Safety Endpoints |
| Any symptomatic intracranial hemorrhage within 48h | 48 hours post-procedure | Secondary Safety Endpoints |
| Any asymptomatic intracranial hemorrhage within 48h | 48 hours post-procedure | Secondary Safety Endpoints |
| Any adverse event | 90±14 days post-procedure | Asymptomatic intracranial hemorrhage |
Countries
China
Contacts
CONTACTWei Hu, MD, PhD
Outcome results
None listed