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A prospective, multicenter, open-label, randomized controlled study to assess the effects of early intensive lipid-lowering initiated before endovascular treatment setting on (i) functional outcome in patients with acute ischemic stroke between preoperative intensive lipid-lowering therapy with PCSK9 inhibitor (PCSK9i) and guideline-recommended standard of care (SoC)(ii) safety in these patients.
As a prospective, multicenter, open-label, randomized controlled clinical study, EAST-LDL will enroll 652 patients with acute ischemic stroke with anterior circulation large vessel occlusion undergoing endovascular treatment from approximately 10 clinical sites in China. This study aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, safety of lipid-lowering therapy, LDL-C goal attainment rate, change in inflammatory markers, incidence of recurrent ischemic stroke events , incidence of symptomatic intracranial hemorrhage transformation within 48 hours, incidence of new-onset hemorrhagic stroke, and incidence of MACEs in patients between early intensive lipid-lowering therapy with PCSK9 inhibitor and guideline-recommended standard of care treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Guideline-recommended standard of care |
|
| Investigational Group | Experimental | Guideline-recommended standard of care+intensive lipid-lowering therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guideline-recommended SoC | Drug | Guideline-recommended SoC, including but not limited to oral lipid-lowering drugs, antiplatelet aggregation drugs, anticoagulant drugs, antihypertensive drugs, etc. It is to be determined by the investigator based on the subject's treatment needs. |
| Measure | Description | Time Frame |
|---|---|---|
| favorable functional outcome (defined as an mRS score of 0-2) | the rate (%) of good functional outcome at 90 days (modified Rankin Scale [mRS] score 0-2). Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| mRS ordinal score | Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. | Day 90 |
| Change from baseline in NIHSS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Li, MD | Contact | 86021-38804518 | 22107 | ligang@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shanghai East Hospital | Tongji University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University | Recruiting | Shanghai | 200127 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2025 |
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| Recaticimab (intensive) | Drug | Recaticimab is added to the guideline-recommended SoC. After randomization and before endovascular interventional treatment, patients will receive a subcutaneous injection of Recaticimab. The specific method is: Recaticimab 450 mg (3 vials) as a single subcutaneous injection, until the end of the follow-up for this study. |
|
0-42, higher scores indicates worse severity |
| Day 14±3 days or before discharge |
| Change from baseline in LDL-C | Change from baseline in LDL-C at 14±3 days or before discharge | Day 14±3 days or before discharge |
| Change in inflammatory markers | Change from baseline in inflammatory markers at 14±3 days or before discharge; | Day 0, Day 14±3 days or before discharge |
| Rate of severe disability(defined as mRS score of 3-5) | Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. | Day 90 |
| Incidence of recurrent ischemic stroke events | Incidence of recurrent ischemic stroke events | From enrollment to the end of treatment at 90 days |
| Incidence of symptomatic intracranial hemorrhage transformation | Incidence of symptomatic intracranial hemorrhage transformation within 24-48h; | Within 24-48 hours |
| Incidence of patients with new hemorrhagic stroke | Incidence of patients with new hemorrhagic stroke | From enrollment to 90 days |
| Incidence of patients with major adverse cardiovascular events | Incidence of major adverse cardiovascular events (MACEs) within 90 days | From enrollment to 90 days |
| Number of patients with serious adverse events | total number of serious adverse events reported during follow-up, according to standard definitions | From enrollment to 90 days |
| Health related quality of life | according to the EQ-5D | Day 90 |
| NIHSS score | 0-42, higher scores indicates worse severity | at 14±3 days or before discharge |
| LDL-C goal attainment rate | LDL-C attained equal or lower than 1.8mmol/L or decrease by equal or more than 50% | at 14±3 days or before discharge |
| Mortality rate | Death within 90 days. | Day 90 |
| May 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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