PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis
NCT07119918 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5276
Last updated 2025-08-13
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.
Conditions
- Symptomatic Intracranial Atherosclerotic Stenosis
Interventions
- DRUG
-
Recaticimab
Recaticimab 300mg subcutaneous Q8W for 1 year.
- DRUG
-
Matched placebo subcutaneous Q8W for 1 year.
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
lead OTHER
Principal Investigators
-
Yamei Tang · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2029-12-01
- Completion
- 2029-12-01
Countries
- China
Study Locations
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