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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
652
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.
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.
Shanghai East Hospital, Tongji University
Shanghai, China
RECRUITINGfavorable 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.
Time frame: Day 90
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.
Time frame: Day 90
Change from baseline in NIHSS score
0-42, higher scores indicates worse severity
Time frame: 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
Time frame: Day 14±3 days or before discharge
Change in inflammatory markers
Change from baseline in inflammatory markers at 14±3 days or before discharge;
Time frame: 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.
Time frame: Day 90
Incidence of recurrent ischemic stroke events
Incidence of recurrent ischemic stroke events
Time frame: 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;
Time frame: Within 24-48 hours
Incidence of patients with new hemorrhagic stroke
Incidence of patients with new hemorrhagic stroke
Time frame: From enrollment to 90 days
Incidence of patients with major adverse cardiovascular events
Incidence of major adverse cardiovascular events (MACEs) within 90 days
Time frame: 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
Time frame: From enrollment to 90 days
Health related quality of life
according to the EQ-5D
Time frame: Day 90
NIHSS score
0-42, higher scores indicates worse severity
Time frame: 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%
Time frame: at 14±3 days or before discharge
Mortality rate
Death within 90 days.
Time frame: Day 90
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