Clinical Trial of PCSK9 Inhibitor and Statin Treatment for Carotid Artery Stenosis

Sponsor
Changhai Hospital
Study ID
NCT07036991
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Carotid Artery Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

A prospective, multicenter, randomized controlled, open-label, blinded outcome evaluation (PROBE) trial.

Key Dates

Start date
Jul 30, 2025
Status verified
Apr 2025
Primary completion
Jun 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
406 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PCSK9 Inhibitor + Statin ± Ezetimibe Group
    PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day
  • Active Comparator: Statin ± Ezetimibe Group
    Rosuvastatin/atorvastatin ± ezetimibe, continued or initiated on randomization day

Primary Outcome Measure

Change in plaque burden rate at the most stenotic carotid site at 180±7 days [ Time Frame: 180±7 days ]

Central Contacts