A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis

Sponsor
Changhai Hospital
Study ID
NCT07036991
Status
Recruiting
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Conditions

  • Carotid Artery Stenosis

Eligibility Criteria

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

Interventions

  • PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe — DRUG
    PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe
  • Rosuvastatin/Atorvastatin ± Ezetimibe — DRUG
    Rosuvastatin/atorvastatin ± ezetimibe

Study Details

A multicenter cohort study

Key Dates

First listed
Jun 25, 2025
Start date
Sep 5, 2025
Status verified
Jul 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
406 participants (estimated)

Arms

  • Arm: Exposure Group: PCSK9 Inhibitor + Statin ± Ezetimibe Group
    PCSK9 inhibitor (biweekly injections) + rosuvastatin/atorvastatin ± ezetimibe, initiated on randomization day
  • Arm: Non-exposed Group: 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