NCT07119918

PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis

PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis (PICASSO): A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,276 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Symptomatic Intracranial Atherosclerotic Stenosis

Interventions

Type	Name	Description
DRUG	Recaticimab	Recaticimab 300mg subcutaneous Q8W for 1 year.
DRUG	Placebo	Matched placebo subcutaneous Q8W for 1 year.

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China