Efficacy and Safety of Early Combined Therapy With PCSK9 Inhibitors and Statins in Acute Ischemic Stroke A Multicenter, Prospective, Randomized Trial

What this Trial Is About

Researchers are investigating the effects of early combination therapy using PCSK9 inhibitors with statins in patients who have moderate or severe symptomatic intracranial large vessel atherosclerotic stenosis sICAS and have suffered an acute ischemic stroke within 48 hours of symptom onset. This randomized controlled trial aims to see if adding PCSK9 inhibitors to standard statin treatment can reduce early neurological worsening and improve recovery outcomes. The study also assesses the safety of this combination therapy compared to statin treatment alone. Participants are randomly assigned to one of two groups. The experimental group receives a single subcutaneous injection of 420 mg evolocumab a PCSK9 inhibitor on admission along with standard doses of atorvastatin 20 mg or rosuvastatin 10 mg and other guideline-based treatments. The control group receives only the standard doses of atorvastatin or rosuvastatin as per current guidelines. This study uses a prospective, open-label, endpoint-blinded design and is conducted across multiple centers. During the trial, participants will be monitored closely for early neurological deterioration within 3 days post-randomization using NIHSS scores and bleeding events using established criteria. Further neurological recovery is tracked up to 90 days, including stroke recurrence and mortality. Assessments include changes in neurological scores, functional disability scales, lipid levels, and safety outcomes. The total follow-up period extends to 90 days to evaluate both efficacy and safety of the combination therapy.

Efficacy and Safety of Early Combined Therapy With PCSK9 Inhibitors and Statins in Acute Ischemic Stroke