Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease (SUCCESS)

Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial

The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease(CAD); Prevention; CT Angiography; Major Adverse Cardiovascular Events (MACE)
• Intervention / Treatment: Diagnostic test: Coronary Computed Tomography Angiography; Other: Current clinical guidelines

Detailed Description

Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients.

The SUCCESS study is a multicenter, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.

• Study Type: Interventional
• Enrollment (Estimated): 3100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Longjiang Zhang, MD; Phone Number: 13405833167; Email: kevinzhlj@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210018
      • Recruiting
      • Research Institute Of Medical Imaging Jinling Hospital
      • Contact: Longjiang Zhang, MD; Phone Number: 13405833176; Email: kevinzhlj@163.com
      • Contact: Chao Li, MD; Phone Number: 18822060230; Email: lclive123123@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 18 and 80 years old;
2. Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
3. Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.

Exclusion Criteria:

1. Patients who have experienced ACS or PCI/CABG;
2. Patients who have experienced adverse cardiovascular and cerebrovascular events;
3. Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
4. Patients with severe hepatic and renal dysfunction;
5. Patients with contraindications to CCTA examinations;
6. Patients with poor initial CCTA image quality or data loss.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CCTA-based follow-up management group; The subjects will undergo routine clinical and laboratory examinations, as well as follow-up CCTA examinations to assess the progression of plaques and to recommend appropriate management, treatment, and follow-up based on the findings	Diagnostic test: Coronary Computed Tomography Angiography; Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment.
Sham Comparator: clinical-based follow-up management group; The subjects will undergo routine clinical and laboratory examinations, and recommendations for appropriate management, treatment, and follow-up will be made based on the results.	Other: Current clinical guidelines; Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular and cerebrovascular event	Record the number of participants experiencing major adverse cardiovascular and cerebrovascular event such as all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke	36 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C control rate	The proportion of participants with controlled LDL-C（<1.4mmol/L）	12 months after baseline
Mean LDL-C changes	Mean LDL-C changes of participants	12 months after baseline
Adherence to lipid-lowering medication rate	The proportion of participants who adhere to lipid-lowering drugs	12 months after baseline
The difference in healthcare-seeking rates between the two groups	The difference in healthcare-seeking rates between the two groups of patients, including both regular follow-ups and visits driven by clinical symptoms of coronary heart disease	12 months after baseline
Hypertension control rate	The proportion of participants with SBP<140mmHg and DBP<90mmHg.	12 months after baseline
Diabetic control rate	The proportion of participants with HbA1c <53 mmol/mol (7.0%).	12 months after baseline
Cardiac death	Number of participants diagnosed with cardiovascular death	36 months after baseline
Fatal and non-fatal myocardial infarction or stroke	Number of participants diagnosed with myocardial infarction or stroke	36 months after baseline
Rehospitalization due to progressive angina	Number of patients seeking medical care for unstable angina	36 months after baseline
Major adverse cardiovascular event	Record the number of participants experiencing major adverse cardiovascular events such as all-cause mortality, non-fatal myocardial infarction and ischemia driven revascularation	36 months after baseline
Procedures	The proportion of participants undergone procedures，including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery	36 months after baseline
Radiation dose and incidental findings from CTCA	The total radiation dose received by the participants during multiple examinations after enrollment.	36 months after baseline
Change in quality of life (SF-12)	Change in quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument	36 months after baseline
The primary outcome in different subgroups	The primary outcome (all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke) will be analyzed in prespecified subgroups, including age, sex, hypertension, diabetes mellitus, degree of stenosis on baseline CCTA.	36 months after baseline

Collaborators and Investigators

• Sponsor: Zhang longjiang,MD
• Investigators: Study Chair: Trail Manager, Jinling Hospital,Nanjing University School of Medicine,Nanjing,China

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2024DZKY-132-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No