NCT05462262

Brief Summary

Current guidelines recommend moderate-intensity lipid-lowering therapy (goal for LDL-C \<2.6 mmol/L or 30%-50% reduction from baseline) for patients with intermediate 10-year ASCVD risk. In these patients, early coronary atherosclerotic plaques detected by coronary CT angiography are common, but further interventions are lacking. This study aims to analyze whether intensive lipid-lowering therapy (goal for LDL-C \<1.8 mmol/L or ≥50% reduction from baseline) could delay the progression of coronary atherosclerotic lesions and reduce the adverse cardiovascular events in these target patients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,900

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2022Oct 2029

First Submitted

Initial submission to the registry

July 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

6.6 years

First QC Date

July 7, 2022

Last Update Submit

January 2, 2026

Conditions

Coronary Artery Disease Progression

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events (MACE)

    Composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina

    Within 3 years after the enrollment

Secondary Outcomes (5)

  • Change in coronary total plaque volume(mm³) on CCTA

    Within 3 years after the enrollment

  • Change in coronary plaque burden(%) on CCTA

    Within 3 years after the enrollment

  • Changes in coronary plaque compositions(mm³, %) on CCTA

    Within 3 years after the enrollment

  • Changes in coronary high-risk plaque characteristics on CCTA

    Within 3 years after the enrollment

  • Change in coronary artery calcium score (CACS) on CT

    Within 3 years after the enrollment

Study Arms (2)

intensive lipid-lowering group

EXPERIMENTAL

Goal for LDL-C \<1.8 mmol/L or ≥50% reduction from baseline.

Drug: Intensive lipid-lowering control

moderate-intensity lipid-lowering group

ACTIVE COMPARATOR

Goal for LDL-C \<2.6 mmol/L or 30%-50% reduction from baseline.

Drug: Moderate-intensity lipid-lowering control

Interventions

Moderate-intensity lipid-lowering controlDRUG

The initial recommended therapy is 10-20mg atorvastatin, and the type and dosage of drugs can be adjusted according to the situation.

Also known as: Standard goal for reducing LDL-C
moderate-intensity lipid-lowering group
Intensive lipid-lowering controlDRUG

The initial recommended therapy is 10-20mg atorvastatin plus Ezetimibe, and the type and dosage of drugs can be adjusted according to the situation.

Also known as: Lower goal for reducing LDL-C
intensive lipid-lowering group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-75 years
  • Low to Intermediate 10-year atherosclerotic cardiovascular disease (ASCVD) risk using pooled cohort equations (PCE).
  • Coronary CT angiography shows atherosclerotic plaque in the main coronary vessels (\>2mm diameter) with luminal stenosis \<70%

You may not qualify if:

  • Combination with serious cardiovascular diseases, including
  • Heart failure (ejection fraction \<30%)
  • Arrhythmias (persistent atrial flutter/atrial fibrillation, second-degree or third-degree atrioventricular block)
  • Hemodynamically important valvular disease
  • Hemodynamically important congenital heart disease
  • Stroke
  • Myocardial infarction, coronary revascularization, or severe/unstable angina before or within 1 month of screening
  • Active liver disease or hepatic dysfunction (defined as alanine aminotransferase or aspartate aminotransferase\> 3 times the upper limit of normal)
  • Unexplained creatine phosphokinase\> 6 times the upper limit of normal
  • Nephrotic syndrome
  • Diabetes mellitus
  • Uncontrollable hypertension
  • Uncontrollable hypothyroidism
  • Hypersensitivity to statins
  • Any planned surgical procedure for the treatment of atherosclerosis
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (4)

  • Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.

    PMID: 31504418BACKGROUND

  • Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.

    PMID: 30879355BACKGROUND

  • Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10.

    PMID: 30586774BACKGROUND

  • Zheng J, Hou Z, Yuan J, Zhao X, Wang Y, Li J, Zhang W, Dou K, Lu B. Effects of intensive lipid lowering compared with moderate-intensity lipid lowering on coronary atherosclerotic plaque phenotype and major adverse cardiovascular events in adults with low to intermediate 10-year ASCVD risk (ILLUMINATION study): protocol for a multicentre, open-label, blinded-endpoint, randomised controlled trial. BMJ Open. 2023 Jun 5;13(6):e070832. doi: 10.1136/bmjopen-2022-070832.

    PMID: 37277217DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
blinded endpoint
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator of National Center for Cardiovascular Diseases and National Clinical Research Center of Cardiovascular Diseases

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 18, 2022

Study Start

October 10, 2022

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)