An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or Recaticimab.
This is an investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial to determine the efficacy of Recaticimab (PCSK9 inhibitor) administered within 7 days of symptom onset in patients with symptomatic intracranial atherosclerotic stenosis (sICAS) in reducing incident stroke within 1 year. Study intervention: (1) Participants in the intervention group will receive Recaticimab 300mg subcutaneous Q8W for 1 year. (2) Participants in the control group will receive matched placebo subcutaneous Q8W for 1 year. All participants will receive best medical management (BMM), including intensive statins treatment and dual antiplatelet therapy. A total of 5276 participants are anticipated to be recruited for this study. Eligible participants will be 1:1 randomly assigned to receive Recaticimab or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
5,276
Recaticimab 300mg subcutaneous Q8W for 1 year.
Matched placebo subcutaneous Q8W for 1 year.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Any new stroke
Any new ischemic or hemorrhagic stroke within 1 year
Time frame: 1 year (±2) weeks
Composite cardiovascular events
Composite cardiovascular events (non-fatal stroke, myocardial infarction, and death from cardiovascular causes) within 1 year.
Time frame: 1 year (±2) weeks
Ischemic stroke
Any new ischemic stroke within 1 year.
Time frame: 1 year (±2) weeks
Hemorrhagic stroke
Any new hemorrhagic stroke within 1 year.
Time frame: 1 year (±2) weeks
Non-fatal stroke
Any non-fatal stroke within 1 year.
Time frame: 1 year (±2) weeks
Myocardial infarction
Any myocardial infarction within 1 year.
Time frame: 1 year (±2) weeks
Death from cardiovascular causes
Any death from cardiovascular causes within 1 year.
Time frame: 1 year (±2) weeks
Quality of life (EQ-5D-5L)
1-year quality of life measured by EQ-5D-5L.
Time frame: 1 year (±2) weeks
NIHSS scores
NIHSS scores at 7 days or discharge.
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Time frame: 7(±1) days or discharge
Modified Rankin Scale score at 90 days
The shift analysis of the 90-day mRS at 90 days.
Time frame: 90 (±14) days
Modified Rankin Scale score at 1 year
The shift analysis of the 90-day mRS at 1 year.
Time frame: 1 year (±2) weeks
Safety outcome: intracranial hemorrhage
Symptomatic intracranial hemorrhage within 1 year.
Time frame: 1 year (±2) weeks
Safety outcome: Death
Death within 1 year.
Time frame: 1 year (±2) weeks
Safety outcome: Serious Adverse Event (SAE)
Any SAE within 1 year.
Time frame: 1 year (±2) weeks