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

RecruitingNAAges 18 Years - 60 YearsAllLiu yong
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intensive lipid-lowering strategy
  • Standard lipid-lowering strategy
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Where

7 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The Ninth Clinical Medical College of Guangzhou University of Chinese Medicine
Dongguan, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
The Eighth Affiliated Hospital of Sun Yat-sen University
Shenzhen, China
Zhongshan People's Hospital
Zhongshan, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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