Status:
RECRUITING
Effect of Intensive Lipid-Lowering Therapy on Coronary Atherosclerotic Plaque Progression in Young and Middle-Aged Patients With Chronic Coronary Syndrome
Lead Sponsor:
Liu yong
Conditions:
Chronic Coronary Syndrome
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 progres...
Detailed Description
Coronary artery disease (CAD) remains the leading cause of mortality worldwide, driven predominantly by the intricate dynamics between lipid metabolism and atherosclerosis. In recent years, the incide...
Eligibility Criteria
Inclusion
- 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
- Left main coronary artery disease or severe three-vessel disease;
- Ultra-high-risk ASCVD patients: ≥2 severe ASCVD events or 1 severe ASCVD event with ≥2 high-risk factors;
- Use of PCSK9 inhibitors or ezetimibe within 8 weeks prior to study enrollment;
- 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).
- Familial hypercholesterolemia;
- Known allergy/intolerance to lipid-lowering drugs used in the trial;
- Patients with severe congestive heart failure, liver or kidney dysfunction, or malignancy;
- Pregnant or breastfeeding female patients.
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
766 Patients enrolled
Trial Details
Trial ID
NCT06896708
Start Date
August 12 2025
End Date
March 1 2028
Last Update
December 17 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400015
2
The Ninth Clinical Medical College of Guangzhou University of Chinese Medicine
Dongguan, Guangdong, China, 523000
3
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510100