Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion
NCT07002476 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 652
Last updated 2026-01-21
Summary
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.
Conditions
Interventions
- DRUG
-
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.
- DRUG
-
Recaticimab (intensive)
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.
Sponsors & Collaborators
-
Shanghai East Hospital
lead OTHER
Principal Investigators
-
Shanghai East Hospital · Tongji University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-19
- Primary Completion
- 2028-06-01
- Completion
- 2029-01-01
Countries
- China
Study Locations
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