Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion
Recruiting
Phase 3Interventional Study
Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
652 (estimated)
Sponsor
Shanghai East Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 interven…
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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;
* Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m2 at final screening;
* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal;
* Severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months;
* Pregnant or lactating women;
* Patients who are participating in other clinical trials;
* Other conditions deemed unsuitable for inclusion in the clinical study by the investigator.
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