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

NCT06338293 | Recruiting Phase 4 DMC

• 1 other identifier: KY20240123-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

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

  one-year

Secondary Outcomes (5)

• The change rate of TAV and plaque load of the target vascular lesion;

  one-year

• The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc.

  one-year

• The change rates of other components of plaque (fiber, calcification, crystal, macrophage)

  one-year

• The change rates of lesion OFR and target vessel OFR

  one-year

• The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.)

  one-year

Study Arms (2)

Inclisiran＋rosuvastatin group

EXPERIMENTAL

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.

Drug: Inclisiran sodium; Drug: Rosuvastatin

Rosuvastatin group

PLACEBO COMPARATOR

Rosuvastatin group: Rosuvastatin 20mg daily for one year.

Drug: Rosuvastatin

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.

Inclisiran＋rosuvastatin group

Rosuvastatin DRUG

Rosuvastatin

Inclisiran＋rosuvastatin group; Rosuvastatin group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

NanJing Frist Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• China Jiangsu

  Nanjin First Hospital,Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peina Meng, MD

CONTACT

8615805199492; 527114121@qq.com

Fei Ye, MD

CONTACT

8618951670287; doctor_ye@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 29, 2024
• Study Start: March 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)