Intensive versus standard cholesterol lowering to slow coronary plaque in young and middle-aged adults with chronic coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized, parallel-group trial enrolling adults aged 18–60 with chronic coronary syndrome managed without revascularization and at least one 50–70% stenosis identified by coronary CT angiography (CCTA). Participants are randomized to an intensive lipid-lowering strategy targeting LDL-C <1.0 mmol/L and ≥50% reduction from baseline or to a guideline-directed strategy targeting LDL-C <1.8 mmol/L and ≥50% reduction. Coronary plaque volume and characteristics are quantified noninvasively by serial CCTA to compare plaque progression between groups. The trial examines whether deeper LDL-C reduction leads to greater plaque stabilization or regression in this younger patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Not yet recruiting
• The Ninth Clinical Medical College of Guangzhou University of Chinese Medicine
  Dongguan, Guangdong, China Not yet recruiting
• The Third Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• The Eighth Affiliated Hospital of Sun Yat-sen University
  Shenzhen, Guangdong, China Not yet recruiting
• Zhongshan People's Hospital
  Zhongshan, Guangdong, China Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.