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sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C>1.8mmol/L) without endovascular therapy.
sICASBLM aims to determine the effectiveness of conventional lipid management combined with PCSK9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (LDL-C>1.8mmol/L) without endovascular therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months |
|
| Control group | No Intervention | Blood Lipid management with atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg for 6-12 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 inhibitor | Drug | The aim is to improve blood lipid management by using atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg and PCSK9 inhibitors for 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent stroke | the recurrent rate of clinical stroke | 6 months-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial arterial | Degree of change in intracranial arterial stenosis | 6 months or 12 months |
| Plaque changes | Plaque volume and load changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junshan Zhou | Contact | 8602587726218 | zhjsh333@126.com | |
| Qiwen Deng | Contact | 8602587726218 | qiw_deng@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42089099 | Derived | Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026. | |
| 40288288 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 6 months or 12 months |
| Vascular remodeling index | Vascular remodeling index changes | 6 months or 12 months |
| Adverse events | The incidence of muscle related events, allergic reactions, injection site reactions, bleeding events and other adverse events was assessed | 6 months or 12 months |
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
| Li Z, Liu X, Sun H, Jiang X, Zhang Y, Ji L, Zhang L, Wang M, Gu M, Li S, Zhang Y, Liu Y, Shi H, Jiang T, Mei Y, Zhu L, Zhou J, Deng Q. Predictors for recurrent ischemic stroke in patients with watershed infarct induced by intracranial artery stenosis. Clin Neurol Neurosurg. 2025 Jul;254:108897. doi: 10.1016/j.clineuro.2025.108897. Epub 2025 Apr 18. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |