Major Adverse Cardiovascular Events (MACE)SUCCESSNCT06843005
Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease
A study testing Coronary Computed Tomography Angiography and Current clinical guidelines in people with Major Adverse Cardiovascular Events (MACE) and Prevention, run by Zhang longjiang,MD at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Adverse Cardiovascular Events (MACE), Prevention, Coronary Artery Disease(CAD)
- What is being tested?
- Coronary Computed Tomography Angiography and Current clinical guidelines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,100 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old;
- Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
- Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.
Who cannot join
- Patients who have experienced ACS or PCI/CABG;
- Patients who have experienced adverse cardiovascular and cerebrovascular events;
- Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
- Patients with severe hepatic and renal dysfunction;
- Patients with contraindications to CCTA examinations;
- Patients with poor initial CCTA image quality or data loss.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, 210018
Longjiang Zhang, MD, 13405833176, kevinzhlj@163.com
Chao Li, MD, 18822060230, lclive123123@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Adverse Cardiovascular Events (MACE), Prevention, Coronary Artery Disease(CAD), CT Angiography
- Being tested
- Coronary Computed Tomography Angiography, Current clinical guidelines
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomography AngiographyDiagnostic test
Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment.
Current clinical guidelinesOther
Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
| Study group | Role | What they receive |
|---|---|---|
| CCTA-based follow-up management group | Active comparator | 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 Receives: Diagnostic Test: Coronary Computed Tomography Angiography |
| clinical-based follow-up management group | Sham comparator | 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. Receives: Other: Current clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months after baseline
Secondary outcomes (14)
LDL-C control rate
The proportion of participants with controlled LDL-C(<1.4mmol/L)
Measured: 12 months after baseline
Mean LDL-C changes
Mean LDL-C changes of participants
Measured: 12 months after baseline
Adherence to lipid-lowering medication rate
The proportion of participants who adhere to lipid-lowering drugs
Measured: 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
Measured: 12 months after baseline
Hypertension control rate
The proportion of participants with SBP<140mmHg and DBP<90mmHg.
Measured: 12 months after baseline
Diabetic control rate
The proportion of participants with HbA1c <53 mmol/mol (7.0%).
Measured: 12 months after baseline
Cardiac death
Number of participants diagnosed with cardiovascular death
Measured: 36 months after baseline
Fatal and non-fatal myocardial infarction or stroke
Number of participants diagnosed with myocardial infarction or stroke
Measured: 36 months after baseline
Rehospitalization due to progressive angina
Number of patients seeking medical care for unstable angina
Measured: 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
Measured: 36 months after baseline
Procedures
The proportion of participants undergone procedures,including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery
Measured: 36 months after baseline
Radiation dose and incidental findings from CTCA
The total radiation dose received by the participants during multiple examinations after enrollment.
Measured: 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
Measured: 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.
Measured: 36 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start28 Feb 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiovascular Events (MACE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang longjiang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang longjiang,MD, Jinling Hospital, China
- Investigators
- Trail Manager, Study chair, Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843005
- Sponsor's protocol ID
- 2024DZKY-132-01
- Acronym
- SUCCESS
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06843005
- Acronym / sponsor ID
- SUCCESS / 2024DZKY-132-01
- Conditions
- Major Adverse Cardiovascular Events (MACE), Prevention, Coronary Artery Disease(CAD), CT Angiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- Zhang longjiang,MDUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCTA-based follow-up management group | Active comparator | Diagnostic Test: Coronary Computed Tomography AngiographyThe 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 |
| clinical-based follow-up management group | Sham comparator | Other: Current clinical guidelinesThe subjects will undergo routine clinical and laboratory examinations, and recommendations for appropriate management, treatment, and follow-up will be made based on the results. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years old;
- Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
- Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.
Key exclusion criteria (6 listed)
- Patients who have experienced ACS or PCI/CABG;
- Patients who have experienced adverse cardiovascular and cerebrovascular events;
- Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
- Patients with severe hepatic and renal dysfunction;
- Patients with contraindications to CCTA examinations;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Computed Tomography AngiographyBased on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment. | Diagnostic test | CCTA-based follow-up management group |
| Current clinical guidelinesPatients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. | Other | clinical-based follow-up management group |
Primary outcome
Major adverse cardiovascular and cerebrovascular event
Time frame: 36 months after baseline
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
14 secondary outcomes
LDL-C control rate
Time frame: 12 months after baseline
Mean LDL-C changes
Time frame: 12 months after baseline
Adherence to lipid-lowering medication rate
Time frame: 12 months after baseline
The difference in healthcare-seeking rates between the two groups
Time frame: 12 months after baseline
Hypertension control rate
Time frame: 12 months after baseline
Diabetic control rate
Time frame: 12 months after baseline
Cardiac death
Time frame: 36 months after baseline
Fatal and non-fatal myocardial infarction or stroke
Time frame: 36 months after baseline
Rehospitalization due to progressive angina
Time frame: 36 months after baseline
Major adverse cardiovascular event
Time frame: 36 months after baseline
Procedures
Time frame: 36 months after baseline
Radiation dose and incidental findings from CTCA
Time frame: 36 months after baseline
Change in quality of life (SF-12)
Time frame: 36 months after baseline
The primary outcome in different subgroups
Time frame: 36 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trail Manager study chair
Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Computed Tomography Angiography and Current clinical guidelines in people with Major Adverse Cardiovascular Events (MACE) and Prevention, run by Zhang longjiang,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longjiang Zhang, MD (13405833167, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular event (time frame: 36 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.