Coronary Artery CalcificationPhase 4DECISION-CALNCT05845424
High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
A Phase 4 study testing Guideline directed statin therapy and High intensity statin plus ezetimibe therapy in people with Coronary Artery Calcification and Metabolic Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Calcification, Metabolic Syndrome, Dyslipidemias
- What is being tested?
- Guideline directed statin therapy and High intensity statin plus ezetimibe therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2023to 30 Jun 2030
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 40 years of age.
- Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100)
- low-density lipoproteins cholesterol (LDL-C) <190 mg/dL
Who cannot join
- Objective evidence of at least moderate inducible ischemia requiring revascularization treatment
- History of cerebrovascular disease
- History of coronary or peripheral arterial revascularization
- Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range
- History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)
- Allergy or sensitivity to any statin or ezetimibe
Show all 10Show fewer
- Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine
- Pregnancy or breast feeding
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Unwillingness or inability to comply with the procedures described in this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
SamsungMedicalCenter
Seoul, 06351
Seunghyuk Choi, PhMD, 82-2-3410-3437
About this study
Official title: Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM (DECISION-CAL)
The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.
Read the detailed description
Atherosclerotic cardiovascular diseases (ASCVD), such as myocardial infarction (MI), ischemic stroke, or peripheral arterial disease, are the leading cause of morbidity and mortality worldwide. The causality of low-density lipoproteins cholesterol (LDL-C) level in the development of ASCVD is well demonstrated in previous studies. After introducing LDL-C lowering agents, multiple large-scale randomized clinical trials have demonstrated lower cardiovascular events with lowering LDL-C levels. In particular, for secondary prevention, more aggressive control of LDL-C levels with high-intensity statin therapy significantly reduced cardiovascular events compared with moderate-intensity statin therapy. In addition, the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) proved the clinical efficacy of additive ezetimibe for incrementally lowering of LDL-C levels in patients with acute coronary syndrome. However, there has been limited evidence regarding the efficacy and safety of aggressive lipid-lowering strategy using high-intensity statin with a combination of ezetimibe for primary prevention of cardiovascular events among persons without cardiovascular disease. Although the Heart Outcomes Prevention Evaluation (HOPE)-3 and Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trials consistently identified that the use of rosuvastatin (10 mg or 20 mg) was significantly associated with reduced future risk of major cardiovascular events in patients who did not have cardiovascular disease, those studies have been focused on the use of statin, not on the intensity of statin.
The coronary artery calcium (CAC) scan, a marker of subclinical coronary atherosclerosis, has become popular for individuals at risk for atherosclerotic cardiovascular disease. CAC is strongly associated with atherosclerotic burden and predicts coronary heart disease events and mortality, regardless of their age, sex, race, or ASCVD risk. Furthermore, the progression of CAC is associated with an increased risk for future hard and total coronary heart disease events. The use of CAC scoring was associated with significant improvements in the reclassification and discrimination of incident ASCVD. Nevertheless, the current guidelines recommend CAC measurement for selected cases only with borderline or intermediate risk of ASCVD to guide the use of statin or not. However, in real-world practice, CAC testing is increasingly being promoted to the public as a means of self-assessment of cardiovascular risk and is widely being used regardless of ASCVD risk. Considering that statin has additional properties, including atherosclerotic plaque stabilization, oxidative stress reduction, enhancement of endothelial function, and a decrease in vascular inflammation beyond their lipid-lowering effect, aggressive treatment with a high-intensity statin plus ezetimibe combination might have beneficial effects on the long-term clinical outcomes for asymptomatic patients with significant coronary calcium (Agatston Score ≥ 100) compared with standard lipid-lowering therapy endorsed by the current guidelines.
Therefore, the purpose of DECISION-CALCIUM (Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM) trial is to compare the efficacy and safety of the aggressive lipid-lowering therapy with combination of high-intensity statin and ezetimibe, compared with the current standard lipid-lowering therapy in asymptomatic patients with significant coronary calcification for primary prevention.
- Being tested
- Guideline directed statin therapy, High intensity statin plus ezetimibe therapy
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline directed statin therapyDrug
At least moderate intensity statin, recommended by the current guideline based on the ASCVD risk
High intensity statin plus ezetimibe therapyDrug
Rosuvastatin 20 mg + Ezetimibe 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Aggressive treatment arm | Experimental | In this group, high-intensity statin (rosuvastatin 20mg) combined with ezetimibe 10 mg will be prescribed regardless of patients' age, concomitant diabetes mellitus, or ASCVD risk. Receives: Drug: High intensity statin plus ezetimibe therapy |
| Standard treatment arm | Active comparator | In this group, lipid lowering therapy will be followed according to the current guideline recommendation. A moderate-intensity statin (rosuvastatin 5 mg) will be prescribed for patients over 75 years of age or with diabetes mellitus. For non-diabetic patients aged 40-75 years, the use of statins will be determined by calculating the ASCVD risk score. (ASCVD risk <7.5%: no statin use, ≥7.5 - <20%: moderate-intensity statin [rosuvastatin 5mg], ≥ 20%: high-intensity statin [rosuvastatin 20mg]) Receives: Drug: Guideline directed statin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
a composite of death from any causes, myocardial infarction, stroke, unplanned coronary revascularization, or other arterial revascularization procedure
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Secondary outcomes (15)
All-cause death
Death from any causes
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Cardiovascular death
Death from cardiovascular causes
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Stroke
Ischemic or hemorrhagic stroke
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Unplanned coronary revascularization
revascularization procedure to coronary artery
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Arterial revascularization procedure
All arterial revascularization procedure
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Major bleeding
Bleeding Academic Research Consortium (BARC) type 3-5
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Bleeding
BARC type 2-5
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Heart failure hospitalization
Hospitalization due to heart failure
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Coronary calcium progression
Delta CAC
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Changes of LDL-C
Delta LDL-C
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
New-onset diabetes mellitus
Occurence of new-onset diabetes mellitus
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Hepatic disorder requiring discontinuation of statin
Occurence of hepatic disorder requiring discontinuation of statin
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
muscle-related adverse events
Occurence of muscle-related adverse events due to statin
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Proportion of patients with LDL-C < 100mg/dL
Proportion of patients with LDL-C < 100mg/dL
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Proportion of patients with LDL-C < 70mg/dL
Proportion of patients with LDL-C < 70mg/dL
Measured: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Jul 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- standard treatment vs. aggressive treatment
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Hyuk Choi, Samsung Medical Center
- Investigators
- Seung-Hyuk Choi, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845424
- Sponsor's protocol ID
- DECISION-CALCIUM
- Acronym
- DECISION-CAL
- Status last verified
- Jan 2025
- First submitted
- 25 Apr 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM (DECISION-CAL)
- ClinicalTrials.gov ID
- NCT05845424
- Acronym / sponsor ID
- DECISION-CAL / DECISION-CALCIUM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 6 May 2023 (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 aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.
Detailed description
Atherosclerotic cardiovascular diseases (ASCVD), such as myocardial infarction (MI), ischemic stroke, or peripheral arterial disease, are the leading cause of morbidity and mortality worldwide. The causality of low-density lipoproteins cholesterol (LDL-C) level in the development of ASCVD is well demonstrated in previous studies. After introducing LDL-C lowering agents, multiple large-scale randomized clinical trials have demonstrated lower cardiovascular events with lowering LDL-C levels. In particular, for secondary prevention, more aggressive control of LDL-C levels with high-intensity statin therapy significantly reduced cardiovascular events compared with moderate-intensity statin therapy. In addition, the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) proved the clinical efficacy of additive ezetimibe for incrementally lowering of LDL-C levels in patients with acute coronary syndrome. However, there has been limited evidence regarding the efficacy and safety of aggressive lipid-lowering strategy using high-intensity statin with a combination of ezetimibe for primary prevention of cardiovascular events among persons without cardiovascular disease. Although the Heart Outcomes Prevention Evaluation (HOPE)-3 and Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trials consistently identified that the use of rosuvastatin (10 mg or 20 mg) was significantly associated with reduced future risk of major cardiovascular events in patients who did not have cardiovascular disease, those studies have been focused on the use of statin, not on the intensity of statin.
The coronary artery calcium (CAC) scan, a marker of subclinical coronary atherosclerosis, has become popular for individuals at risk for atherosclerotic cardiovascular disease. CAC is strongly associated with atherosclerotic burden and predicts coronary heart disease events and mortality, regardless of their age, sex, race, or ASCVD risk. Furthermore, the progression of CAC is associated with an increased risk for future hard and total coronary heart disease events. The use of CAC scoring was associated with significant improvements in the reclassification and discrimination of incident ASCVD. Nevertheless, the current guidelines recommend CAC measurement for selected cases only with borderline or intermediate risk of ASCVD to guide the use of statin or not. However, in real-world practice, CAC testing is increasingly being promoted to the public as a means of self-assessment of cardiovascular risk and is widely being used regardless of ASCVD risk. Considering that statin has additional properties, including atherosclerotic plaque stabilization, oxidative stress reduction, enhancement of endothelial function, and a decrease in vascular inflammation beyond their lipid-lowering effect, aggressive treatment with a high-intensity statin plus ezetimibe combination might have beneficial effects on the long-term clinical outcomes for asymptomatic patients with significant coronary calcium (Agatston Score ≥ 100) compared with standard lipid-lowering therapy endorsed by the current guidelines.
Therefore, the purpose of DECISION-CALCIUM (Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM) trial is to compare the efficacy and safety of the aggressive lipid-lowering therapy with combination of high-intensity statin and ezetimibe, compared with the current standard lipid-lowering therapy in asymptomatic patients with significant coronary calcification for primary prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- standard treatment vs. aggressive treatment
| Arm | Type | Receives |
|---|---|---|
| Aggressive treatment arm | Experimental | Drug: High intensity statin plus ezetimibe therapyIn this group, high-intensity statin (rosuvastatin 20mg) combined with ezetimibe 10 mg will be prescribed regardless of patients' age, concomitant diabetes mellitus, or ASCVD risk. |
| Standard treatment arm | Active comparator | Drug: Guideline directed statin therapyIn this group, lipid lowering therapy will be followed according to the current guideline recommendation. A moderate-intensity statin (rosuvastatin 5 mg) will be prescribed for patients over 75 years of age or with diabetes mellitus. For non-diabetic patients aged 40-75 years, the use of statins will be determined by calculating the ASCVD risk score. (ASCVD risk <7.5%: no statin use, ≥7.5 - <20%: moderate-intensity statin [rosuvastatin 5mg], ≥ 20%: high-intensity statin [rosuvastatin 20mg]) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be at least 40 years of age.
- Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100)
- low-density lipoproteins cholesterol (LDL-C) <190 mg/dL
Key exclusion criteria (10 listed)
- Objective evidence of at least moderate inducible ischemia requiring revascularization treatment
- History of cerebrovascular disease
- History of coronary or peripheral arterial revascularization
- Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range
- History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)
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 |
|---|---|---|
| Guideline directed statin therapyAt least moderate intensity statin, recommended by the current guideline based on the ASCVD risk | Drug | Standard treatment arm |
| High intensity statin plus ezetimibe therapyRosuvastatin 20 mg + Ezetimibe 10 mg | Drug | Aggressive treatment arm |
Primary outcome
Major adverse cardiovascular events
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
a composite of death from any causes, myocardial infarction, stroke, unplanned coronary revascularization, or other arterial revascularization procedure
15 secondary outcomes
All-cause death
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Cardiovascular death
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Stroke
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Unplanned coronary revascularization
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Arterial revascularization procedure
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Major bleeding
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Bleeding
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Heart failure hospitalization
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Coronary calcium progression
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Changes of LDL-C
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
New-onset diabetes mellitus
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Hepatic disorder requiring discontinuation of statin
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
muscle-related adverse events
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Proportion of patients with LDL-C < 100mg/dL
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
Proportion of patients with LDL-C < 70mg/dL
Time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)
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 14 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Seung-Hyuk Choi principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guideline directed statin therapy and High intensity statin plus ezetimibe therapy in people with Coronary Artery Calcification and Metabolic Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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 10 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 14 Jan 2025. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Seung-Hyuk Choi, MD (82-2-3410-3419, sh1214.choi@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: up to 4.5 years of median follow-up (till 3 year after the last patient enrollment)). 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 14 Jan 2025.