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This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on improving cardiovascular events. However, existing studies have focused almost exclusively on the long-term effects of Evolocumab, and the early effects of Evolocumab on AIS patients remains unclear.
Patients aged 18-80 years old admitted to the Department of Neurology, Xuanwu Hospital, Capital Medical University, with a definite diagnosis of acute ischemic stroke and receiving lipid-lowering therapy with statins with or without evolocumab will be included in this study. Participants will be divided into two groups according to the lipid-lowering therapy they used: 1) statin-alone group: the participants receive statins alone (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) for lipid reduction, and 2) PCSK9-i group: the participants receive statins (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) and evolocumab (140mg twice a month) for lipid reduction. Most importantly, the lipid-lowering therapy of participants will be decided only by clinicians not involved in the study, not by the investigators. The levels of blood lipid (TC, TG, HDL-C, LDL-C, Apo AI and Apo B) and inflammatory biomarkers (hsCRP and IL-6) of these participants at different time points (day 1, day 3, day 5, and month 3) will be recorded. The target level of LDL-C is the LDL-C reduction ≥50% from the baseline and LDL-C<1.4mmol/L (55mg/dL). In addition, the cardiovascular events and adverse drug reactions of these participants during follow-up will also be recorded. During the follow-up period (3 months), participants who changed their lipid-lowering regimen, including the type, dosage and frequency of statins and evolocumab, will be excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin-alone group | The participants in statin-alone group receive statins alone for lipid reduction. |
| |
| PCSK9-i group | The participants in PCSK9-i group receive statins and evolocumab for lipid reduction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Statins | Drug | Atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C target achievement rate on Day 5, Month 3 | LDL-C target achievement rate= Number of patients who achieved the LDL-C target level/ Total number of follow-up patients | Day 5, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in LDL-C level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in LDL-C level= (follow-up LDL-C level - baseline LDL-C level)/ baseline LDL-C level | Day 1, Day 3, Day 5, Month 3 |
| Percentage change in HDL-C level on Day 1, Day 3, Day 5, and Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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Acute ischemic stroke patients aged 18 to 80 years
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Ran, PhD | Contact | +86-10-83199280 | victor65@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Ran, PhD | Xuanwu Hospital, Beijing | Study Chair |
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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 |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| C577155 | evolocumab |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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| Evolocumab | Drug | Evolocumab 140mg twice a month, subcutaneous injection |
|
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Percentage change in HDL-C level= (follow-up HDL-C level - baseline HDL-C level)/ baseline HDL-C level |
| Day 1, Day 3, Day 5, Month 3 |
| Percentage change in TC level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in TC level= (follow-up TC level - baseline TC level)/ baseline TC level | Day 1, Day 3, Day 5, Month 3 |
| Percentage change in TG level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in TG level= (follow-up TG level - baseline TG level)/ baseline TG level | Day 1, Day 3, Day 5, Month 3 |
| Percentage change in Apo AI level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in Apo AI level= (follow-up Apo AI level - baseline Apo AI level)/ baseline Apo AI level | Day 1, Day 3, Day 5, Month 3 |
| Percentage change in Apo B level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in Apo B level= (follow-up Apo B level - baseline Apo B level)/ baseline Apo B level | Day 1, Day 3, Day 5, Month 3 |
| Percentage change in hsCRP level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in hsCRP level= (follow-up hsCRP level - baseline hsCRP level)/ baseline hsCRP level | Day 1, Day 3, Day 5, Month 3 |
| Percentage change in IL-6 level on Day 1, Day 3, Day 5, and Month 3 | Percentage change in IL-6 level= (follow-up IL-6 level - baseline IL-6 level)/ baseline IL-6 level | Day 1, Day 3, Day 5, Month 3 |
| Percentage of mRS≤2 on Month 3 | Percentage of mRS≤2= Number of patients with mRS≤2/ Total number of follow-up patients | Month 3 |
| Incidence of major cardiovascular events on Month 3 | Major cardiovascular events: stroke, cardiovascular death, myocardial infarction, hospitalization for unstable angina, and coronary revascularization. | Month 3 |
| Incidence of adverse events on Month 3 | Adverse events: injection site reaction, anaphylaxis, myopathy, abnormal liver function, new onset diabetes, cognitive impairment, and hemorrhagic cerebral infarction. | Month 3 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |