A Phase 3 interventional study of guideline-recommended SoC and Recaticimab (intensive) in Stroke, sponsored by Shanghai East Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Shanghai East Hospital · Phase 3, Interventional, and Treatment
EAST-LDL is a prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment evaluating whether early intensive lipid lowering with the PCSK9 inhibitor recaticimab, administered before endovascular therapy, improves functional outcome in patients with acute ischemic stroke due to anterior-circulation large-vessel occlusion. Participants are randomized to recaticimab plus guideline-recommended standard of care or standard of care alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 ± 7 days.
EAST-LDL is an investigator-initiated, prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment conducted at approximately 20 stroke centers in China. Adults with acute ischemic stroke due to anterior-circulation large-vessel occlusion who are planned to undergo endovascular therapy within 24 hours of symptom onset or last known well are randomized 1:1 to the PCSK9 inhibitor group or the control group. Participants assigned to the PCSK9 inhibitor group receive guideline-recommended standard of care plus recaticimab 450 mg administered subcutaneously after randomization and before the first thrombectomy pass, whereas participants assigned to the control group receive guideline-recommended standard of care alone.
The original target sample size was 652 participants. The protocol prespecified one sample-size re-estimation after approximately 50% of the initially planned participants had completed the 90-day primary outcome assessment. Following the prespecified re-estimation, the independent Data and Safety Monitoring Board recommended at its third meeting on August 3, 2026 that the total sample size be increased by 50%, from 652 to 978 participants, in accordance with the predefined adaptive rules. No unblinded treatment results were disclosed to the investigators or other members of the blinded study team. The current target sample size is therefore 978 participants.
The primary outcome is favorable functional outcome at 90 ± 7 days, defined as a modified Rankin Scale (mRS) score of 0-2. Secondary efficacy outcomes include the ordinal distribution of mRS scores, National Institutes of Health Stroke Scale (NIHSS) score and change from baseline, low-density lipoprotein cholesterol (LDL-C) goal attainment and change from baseline, changes in inflammatory markers, severe disability, all-cause mortality, recurrent ischemic stroke, new hemorrhagic stroke, major adverse cardiovascular events, and health-related quality of life assessed using the EuroQol 5-Dimension questionnaire. Safety outcomes include symptomatic intracranial hemorrhagic transformation, serious adverse events, and adverse events of special interest. The 90-day mRS outcome is assessed centrally by an independent Outcome Assessment Committee blinded to treatment allocation.
Exclusion Criteria:
Guideline-recommended standard of care
Drug: guideline-recommended SoC
Guideline-recommended standard of care+intensive lipid-lowering therapy
Drug: Recaticimab (intensive)
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.
450 mg as three 150-mg subcutaneous injections after randomization and before the first thrombectomy pass. No additional PCSK9 inhibitor treatment is planned during the 90-day follow-up.
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.
Time frame: 90 ± 7 days
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: 90 ± 7 days
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: 90 ± 7 days
Incidence of recurrent ischemic stroke events
Incidence of recurrent ischemic stroke events
Time frame: From randomization through Day 90
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 randomization through Day 90
Incidence of patients with major adverse cardiovascular events
Incidence of major adverse cardiovascular events (MACEs) within 90 days
Time frame: From randomization through Day 90
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: 90 ± 7 days
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 (70 mg/dL)
Time frame: at 14±3 days or before discharge
Mortality rate
Death within 90 days.
Time frame: 90 ± 7 days
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Shanghai East Hospital