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

ConditionStroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai East Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adults (age 18 years and older);

Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2);

Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;

Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements).

Disqualifiers

ASPECTS score ≤5 on cranial CT imaging;

Pre-existing functional impairment, with mRS score >2;

Patients who are allergic to PCSK9 inhibitors;

Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;

Trial design

Treatments tested in this trial

  • guideline-recommended SoC
  • Recaticimab (intensive)

Treatment groups

652 Participants
are divided into 2 treatment groups

Sponsors and collaborators