Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion

Condition(s) studied

Investigational drug(s) / intervention(s)

guideline-recommended SoC: 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 (intensive): 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• favorable functional outcome (defined as an mRS score of 0-2) — 90 ± 7 days
  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.

Trial sites (1)

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