Effect of Intensive Lipid-Lowering Therapy on Coronary Atherosclerotic Plaque Progression in Young and Middle-Aged Patients With Chronic Coronary Syndrome

NCT06896708 · tracked via the Priya Life Science China tracker

Sponsor

Liu yong

Phase

Not applicable

Started

2025-08-12

Last updated

2025-12-17

Condition(s) studied

Chronic Coronary Syndrome

Investigational drug(s) / intervention(s)

Intensive lipid-lowering strategyStandard lipid-lowering strategy

Intensive lipid-lowering strategy: The initial recommended therapy is 20mg atorvastatin/10mg rosuvastatin plus Ezetimibe or PCSK9i, and the type and dosage of drugs can be adjusted according to the situation. If the target LDL-C level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.

Standard lipid-lowering strategy: The initial recommended therapy is 20mg atorvastatin/10mg rosuvastatin, and the type and dosage of drugs can be adjusted according to the situation. If the target L-DLC level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.

Study summary

This is a multicenter, open-label, parallel-group, randomized trial to determine if intensive lipid-lowering therapy (goal for LDL-C \<1.0 mmol/L and ≥50% reduction frome baseline) could delay progression of coronary atherosclerotic obstructive leisions compared with guideline recommended lipid-lowering therapy (goal for LDL-C \<1.8 mmol/L and ≥50% reduction frome baseline) among participants between 18-60 years old with non-invasively managed chronic coronary syndrome (at least one lesion with a 50%-70% stenosis).

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: 1\. Aged 18-60 years at screening 2. Stable angina symptoms with suspected or confirmed coronary artery disease; 2. CCTA examination demonstrating: at least one major coronary artery with a diameter of ≥1.5mm that has not been intervened and at least one leision with 50%-70% stenosis. 3\. Subjects who have been using statin therapy alone for at least 4 weeks prior to enrollment with a baseline LDL-C ≥1.8mmol/L or subjects who have not initiated lipid-lowering therapy prior to enrollment with a baseline LDL-C≥2.6mmol/L. Exclusion Criteria: 1. Left main coronary artery disease or severe three-vessel disease; 2. Ultra-high-risk ASCVD patients: ≥2 severe ASCVD events or 1 severe ASCVD event with ≥2 high-risk factors; 3. Use of PCSK9 inhibitors or ezetimibe within 8 weeks prior to study enrollment; 4. The baseline LDL-C was relatively high (LDL-C≥2.6 mmol/L in those taking statins and ≥4.9 mmol/L in those not taking statins). 5. Familial hypercholesterolemia; 6. Known allergy/intolerance to lipid-lowering drugs used in the trial; 7. Patients with severe congestive heart failure, liver or kidney dysfunction, or malignancy; 8. Pregnant or breastfeeding female patients.

Primary outcome measure(s)

The composite events of atherosclerotic plaque progression — 12 months
A composite end-point comprised of plaque progression, nonfatal myocardial infarction, death, or unstable angina driven rehospitalization or revascularization. Plaque progression is defined as an anual progression of PAV measured by CCTA more than 1%. PAV = (total plaque volume/vessel volume) \*100%.

Trial sites (7)

Facility	City	Region	Status
The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Not Yet Recruiting
The Ninth Clinical Medical College of Guangzhou University of Chinese Medicine	Dongguan	Guangdong	Not Yet Recruiting
The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	Not Yet Recruiting
Guangdong Provincial People's Hospital	Guangzhou	Guangdong	Recruiting
The Eighth Affiliated Hospital of Sun Yat-sen University	Shenzhen	Guangdong	Not Yet Recruiting
Zhongshan People's Hospital	Zhongshan	Guangdong	Not Yet Recruiting
The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06896708 on ClinicalTrials.gov ↗ ← All trials in China