Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques

Sponsor
Nanjing First Hospital, Nanjing Medical University
Study ID
NCT06338293
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Inclisiran sodium — DRUG
    The patients in Inclisiran group were given drugs three times in total. The first needle was injected subcutaneously with 284mg(1.5ml solution) after entering the group, the second needle was injected three months later and the third needle was injected at the ninth month.
  • Rosuvastatin — DRUG
    Rosuvastatin

Study Details

Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques.

Key Dates

Start date
Mar 15, 2024
Status verified
Feb 2025
Primary completion
Jun 30, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Inclisiran＋rosuvastatin group
    Inclisiran sodium＋rosuvastatin 20mg group: Rosuvastatin was given 20mg daily for one year, and Inclisiran was given three times in total. After the first injection, 284mg(1.5ml solution) was injected subcutaneously, the second injection was 3 months after the first injection, and the third injection was in the ninth month.
  • Placebo Comparator: Rosuvastatin group
    Rosuvastatin group: Rosuvastatin 20mg daily for one year.

Primary Outcome Measure

The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%) [ Time Frame: one-year ]

Central Contacts

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