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

NCT06896708 | Recruiting DMC

• 1 other identifier: KY2025-394-02
• Study Type: interventional
• Target: 766
• Locations: 1 country
• Sites: 7

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 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).

Conditions

Chronic Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• The composite events of atherosclerotic plaque progression

  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%.

  12 months

Secondary Outcomes (10)

• Major adverse cardiac events

  12 months

• Plaque progression event

  12 months

• Agatston score changes of coronary artery and aortic valve

  12 months

• Percentage change in total coronary atheroma volume

  12 months

• Change in non-obstructive lesion reversal rate

  12 months

Study Arms (2)

Intensive lipid-lowering strategy

EXPERIMENTAL

LDL-C reduce to \<1.0mmol/L and by ≥50% relative to baseline levels.

Drug: Intensive lipid-lowering strategy

Standard lipid-lowering strategy

ACTIVE COMPARATOR

LDL-C reduce to \<1.8mmol/L and by ≥50% relative to baseline levels.

Drug: Standard lipid-lowering strategy

Interventions

Standard lipid-lowering strategy DRUG

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.

Standard lipid-lowering strategy

Intensive lipid-lowering strategy DRUG

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.

Intensive lipid-lowering strategy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liu yong: lead

Study Sites (7)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400015, China

NOT YET RECRUITING

The Ninth Clinical Medical College of Guangzhou University of Chinese Medicine

Dongguan, Guangdong, 523000, China

NOT YET RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510100, China

RECRUITING

The Eighth Affiliated Hospital of Sun Yat-sen University

Shenzhen, Guangdong, 518033, China

NOT YET RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528400, China

NOT YET RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

NOT YET RECRUITING

Related Publications (4)

• Mendieta G, Pocock S, Mass V, Moreno A, Owen R, Garcia-Lunar I, Lopez-Melgar B, Fuster JJ, Andres V, Perez-Herreras C, Bueno H, Fernandez-Ortiz A, Sanchez-Gonzalez J, Garcia-Alvarez A, Ibanez B, Fuster V. Determinants of Progression and Regression of Subclinical Atherosclerosis Over 6 Years. J Am Coll Cardiol. 2023 Nov 28;82(22):2069-2083. doi: 10.1016/j.jacc.2023.09.814.

  PMID: 37993199 RESULT

• Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.

  PMID: 39210710 RESULT

• Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.

  PMID: 35368058 RESULT

• Mensah GA, Fuster V, Murray CJL, Roth GA; Global Burden of Cardiovascular Diseases and Risks Collaborators. Global Burden of Cardiovascular Diseases and Risks, 1990-2022. J Am Coll Cardiol. 2023 Dec 19;82(25):2350-2473. doi: 10.1016/j.jacc.2023.11.007. No abstract available.

  PMID: 38092509 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 26, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)