Coronary Artery Disease ProgressionILLUMINATIONNCT05462262
Intensive Lipid-lowering for Plaque and Major Adverse Cardiovascular Events in Low to Intermediate 10-year ASCVD Risk Population
A study of Coronary Artery Disease Progression, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease Progression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 21Show fewer
- 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
- Gastrointestinal diseases affecting drug absorption or history of gastrointestinal surgery
- Survival-limiting diseases
- Concurrent long-term immunosuppressive therapy
- Participation in another clinical trial concurrently or within 30 days before screening
- Pregnant or breastfeeding
- Other unsuitable situations deemed by physicians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intensive Lipid-lowering on Coronary Atherosclerotic Plaque Phenotype and Major Adverse Cardiovascular Events in Adults With Low to Intermediate 10-year ASCVD Risk: a Prospective, Randomized, Open-label, Blinded Endpoint Analysis(PROBE)
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.
Read the detailed description
Both American (2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease) and European (2019 ESC/EAS Guidelines for the management of dyslipidemias) guidelines currently recommended moderate-intensity lipid-lowering (goal for LDL-C <2.6 mmol/L or 30%-50% reduction from baseline) for primary prevention in the population at intermediate (or borderline) 10-year ASCVD risk, but the residual risk in this group of the population remains to be explored, especially in a subset with only nonobstructive atherosclerotic plaques detected by CCTA, for whom further risk stratification and precise interventions for primary prevention are lacking.
CCTA could show accurate images of patients' early coronary atherosclerotic lesions and provides a wealth of image-based anatomical and functional information including plaque burden (total plaque volume, calcification score, segment involvement score, etc.), plaque composition, high-risk plaque characteristics, luminal stenosis, and CT-FFR. With this complete imaging information on CCTA, there is an urgent need to investigate primary prevention strategies and the evidence-based rationale for performing precise risk stratification in low to intermediate-risk populations with nonobstructive coronary atherosclerotic lesions using CCTA.
A prospective, randomized, open-label, blinded endpoint analysis (PROBE) will be conducted in the population at clinical low to intermediate 10-year ASCVD risk with nonobstructive coronary atherosclerotic lesions, predominantly non-calcified plaques detected by CCTA. The purpose of this study is to demonstrate that intensive lipid-lowering could slow down plaque progression and reduce the incidence of MACE in the target population, which provides an evidence-based rationale for further risk re-stratification. Enrolled people will be randomized into the intervention group (goal for LDL-C <1.8 mmol/L or ≥50% reduction from baseline) and the control group (goal for LDL-C <2.6 mmol/L or 30%-50% reduction from baseline).
- Conditions
- Coronary Artery Disease Progression
- Being tested
- Intensive lipid-lowering control, Moderate-intensity lipid-lowering control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lipid-lowering controlDrug
Also called Lower goal for reducing LDL-C
The initial recommended therapy is 10-20mg atorvastatin plus Ezetimibe, and the type and dosage of drugs can be adjusted according to the situation.
Moderate-intensity lipid-lowering controlDrug
Also called Standard goal for reducing LDL-C
The initial recommended therapy is 10-20mg atorvastatin, and the type and dosage of drugs can be adjusted according to the situation.
| Study group | Role | What they receive |
|---|---|---|
| intensive lipid-lowering group | Experimental | Goal for LDL-C <1.8 mmol/L or ≥50% reduction from baseline. Receives: 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. Receives: Drug: Moderate-intensity lipid-lowering control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina
Measured: Within 3 years after the enrollment
Secondary outcomes (5)
Change in coronary total plaque volume(mm³) on CCTA
Total plaque volume(mm³) is defined as the sum of all plaque volumes for coronary arteries.
Measured: Within 3 years after the enrollment
Change in coronary plaque burden(%) on CCTA
Plaque burden(%)=(plaque area/vessel area)×100%
Measured: Within 3 years after the enrollment
Changes in coronary plaque compositions(mm³, %) on CCTA
Plaque compositions include lipid(<30 HU), fibrous(30-150HU), and calcified plaque(>350HU).
Measured: Within 3 years after the enrollment
Changes in coronary high-risk plaque characteristics on CCTA
High-risk plaque characteristics are defined as positive remodeling(remodeling index, >1.1), low CT attenuation (mean CT number <30 HU), spotty calcification(punctate calcium within a plaque measuring less than 3 mm in all dimensions), or napkin-ring sign (a ringlike peripheral higher attenuation with central low CT attenuation).
Measured: Within 3 years after the enrollment
Change in coronary artery calcium score (CACS) on CT
CACS is a quantification of all coronary calcification by the scoring algorithm proposed by Agatston et al.
Measured: Within 3 years after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start10 Oct 2022
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease ProgressionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462262
- Sponsor's protocol ID
- 2021-CXGC03-3
- Acronym
- ILLUMINATION
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31504418Arnett 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.
PubMed 30879355Grundy 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.
PubMed 30586774Zheng 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.
PubMed 37277217
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Lipid-lowering on Coronary Atherosclerotic Plaque Phenotype and Major Adverse Cardiovascular Events in Adults With Low to Intermediate 10-year ASCVD Risk: a Prospective, Randomized, Open-label, Blinded Endpoint Analysis(PROBE)
- ClinicalTrials.gov ID
- NCT05462262
- Acronym / sponsor ID
- ILLUMINATION / 2021-CXGC03-3
- Conditions
- Coronary Artery Disease Progression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Both American (2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease) and European (2019 ESC/EAS Guidelines for the management of dyslipidemias) guidelines currently recommended moderate-intensity lipid-lowering (goal for LDL-C <2.6 mmol/L or 30%-50% reduction from baseline) for primary prevention in the population at intermediate (or borderline) 10-year ASCVD risk, but the residual risk in this group of the population remains to be explored, especially in a subset with only nonobstructive atherosclerotic plaques detected by CCTA, for whom further risk stratification and precise interventions for primary prevention are lacking.
CCTA could show accurate images of patients' early coronary atherosclerotic lesions and provides a wealth of image-based anatomical and functional information including plaque burden (total plaque volume, calcification score, segment involvement score, etc.), plaque composition, high-risk plaque characteristics, luminal stenosis, and CT-FFR. With this complete imaging information on CCTA, there is an urgent need to investigate primary prevention strategies and the evidence-based rationale for performing precise risk stratification in low to intermediate-risk populations with nonobstructive coronary atherosclerotic lesions using CCTA.
A prospective, randomized, open-label, blinded endpoint analysis (PROBE) will be conducted in the population at clinical low to intermediate 10-year ASCVD risk with nonobstructive coronary atherosclerotic lesions, predominantly non-calcified plaques detected by CCTA. The purpose of this study is to demonstrate that intensive lipid-lowering could slow down plaque progression and reduce the incidence of MACE in the target population, which provides an evidence-based rationale for further risk re-stratification. Enrolled people will be randomized into the intervention group (goal for LDL-C <1.8 mmol/L or ≥50% reduction from baseline) and the control group (goal for LDL-C <2.6 mmol/L or 30%-50% reduction from baseline).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive lipid-lowering group | Experimental | Drug: Intensive lipid-lowering controlGoal for LDL-C <1.8 mmol/L or ≥50% reduction from baseline. |
| moderate-intensity lipid-lowering group | Active comparator | Drug: Moderate-intensity lipid-lowering controlGoal for LDL-C <2.6 mmol/L or 30%-50% reduction from baseline. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (21 listed)
- Combination with serious cardiovascular diseases, including
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lipid-lowering controlAlso: Lower goal for reducing LDL-CThe initial recommended therapy is 10-20mg atorvastatin plus Ezetimibe, and the type and dosage of drugs can be adjusted according to the situation. | Drug | intensive lipid-lowering group |
| Moderate-intensity lipid-lowering controlAlso: Standard goal for reducing LDL-CThe initial recommended therapy is 10-20mg atorvastatin, and the type and dosage of drugs can be adjusted according to the situation. | Drug | moderate-intensity lipid-lowering group |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: Within 3 years after the enrollment
Composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina
5 secondary outcomes
Change in coronary total plaque volume(mm³) on CCTA
Time frame: Within 3 years after the enrollment
Change in coronary plaque burden(%) on CCTA
Time frame: Within 3 years after the enrollment
Changes in coronary plaque compositions(mm³, %) on CCTA
Time frame: Within 3 years after the enrollment
Changes in coronary high-risk plaque characteristics on CCTA
Time frame: Within 3 years after the enrollment
Change in coronary artery calcium score (CACS) on CT
Time frame: Within 3 years after the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 31504418Mach 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.
- Background: PubMed 30879355Arnett 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.
- Background: PubMed 30586774Grundy 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.
- Derived from this study: PubMed 37277217Zheng 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.
- China-PAR 10-year ASCVD risk modelLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Coronary Artery Disease Progression, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: Within 3 years after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462262, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.