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This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy plus PCSK9 inhibitor | Experimental | Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after endovascular therapy, followed by subsequent subcutaneous injections of Evolocumab (420 mg) or Alirocumab (150 mg) every 4 weeks, for a total of 3 administrations. |
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| Standard therapy alone | No Intervention | Patients in the Standard therapy alone (control) group will receive standard of care treatment. If low-density lipoprotein cholesterol (LDL-C) levels fail to meet target goals after 7 days, cholesterol absorption inhibitors (e.g., Ezetimibe or Hypemab) may be administered. If LDL-C levels still remain suboptimal after 1 month, PCSK9 inhibitors may be added to the treatment regimen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 inhibitor | Drug | PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitors are a class of monoclonal antibody drugs that lower low-density lipoprotein cholesterol (LDL-C) by inhibiting the PCSK9 protein, which increases the liver's ability to remove LDL-C from the blood. This intervention involves the use of established PCSK9 inhibitor agents. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points | The proportion of mordified Rankin Scale of 0 to 2 points at 90 days | 90 days after the stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with early neurological improvement | Defined as a reduction of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) score or a complete resolution of neurological deficits (NIHSS=0) within 7 days after treatment. | 7 days post-treatment |
| Incidence of target vessel reocclusion or recurrent infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaibin Huang, Ph.D. | Contact | +8615915751065 | hkb@smu.edu.cn | |
| Suyue Pan, Ph.D. | Contact | +86 02062787648 | pansuyue@smu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China | |||
| Dongguan Donghua Hospital |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
| C571059 | alirocumab |
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Reocclusion of the responsible vessel confirmed by CTA/MRA/DSA, or new cerebral infarction in the same territory confirmed by diffusion-weighted MRI. |
| 90 days after the stroke onset |
| Reduction amplitude of low-density lipoprotein (LDL-C) | Absolute and relative reduction of LDL-C levels from baseline to Day 7. | Within 7 days post-treatment |
| Mortality rate | All-cause mortality at 90 days. | 90 days after the stroke onset |
| Incidence of symptomatic hemorrhagic transformation | Hemorrhagic transformation associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI. | Within 7 days post-treatment |
| Incidence of acute liver injury | Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal. | Within 90 days post-treatment |
| Proportion of patients with early neurological deterioration | Defined as an increase of ≥4 points on the NIHSS score within 7 days post-treatment. | Within 7 days post-treatment |
| Distribution of modified Rankin Scale (mRS) scores | Shift analysis of mRS scores at 90 days (range 0-6). | 90 days after the stroke onset |
| Incidence of malignant brain edema | Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns. | 48 to 96 hours after onset |
| Midline shift distance | Maximum distance of midline shift (in millimeters) measured on axial CT or MRI. | 72 to 96 hours after onset |
| Incidence of adverse events | All adverse events and serious adverse events, recorded and graded according to CTCAE v5.0. | Within 90 days post-treatment |
| Dongguan |
| Guangdong |
| China |
| Dongguan People's Hospital | Dongguan | Guangdong | China |
| Huadu District People's Hospital of Guangzhou | Guangzhou | Guangdong | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Heyuan People's Hospital | Heyuan | Guangdong | China |
| Hengzhou City People's Hospital, Guangxi | Hengzhou | Guangxi (Autonomous Region) | China |
|
| Hainan Provincial Hospital of Traditional Chinese Medicine | Haikou | Hainan | 570100 | China |
| Haikou People's Hospital | Haikou | Hainan | China |
| Hainan Provincial People's Hospital | Haikou | Hainan | China |
| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | China |
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| Ganzhou City People's Hospital | Ganzhou | Jiangxi | China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |