Coronary Artery DiseasePhase 4ALMIGHTYNCT06186037
Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention
A Phase 4 study testing Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg and Mono drug group of Rosuvastatin 20 mg in people with Coronary Artery Disease and Dyslipidemias, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
[Purpose of the Clinical Study]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease without percutaneous coronary intervention to confirm… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Dyslipidemias, Primary Prevention
- What is being tested?
- Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg and Mono drug group of Rosuvastatin 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,356 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2024to 28 Feb 2029
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adjusts (19 or older)
- Patients with suspected stable angina pectoris without coronary artery interventions, who showed a minimal to intermediate coronary artery diseases (a stenosis of 10 to 70% diameter as per QCA) in at least one natural coronary artery in coronary artery angiography or coronary artery CT.
- Patients who gave their informed consent themselves in writing.
- Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines.
Who cannot join
- Patients with an intermediate (>30%) lesion on the left main coronary artery.
- Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)
- Patients who received percutaneous coronary intervention
- Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases.
- Patients diagnosed with variant myocardial infarction
- Patients with severe liver diseases or lung diseases and/or malignant tumor with life expectancy of less than 3 years
Show all 12Show fewer
- Patients with severe valvular heart disease
- Patients who are hypersensitive or prohibited from using the active substance (Ezetimibe or Rosuvastatin) of the study medicines
- Patients with cardiogenic shock
- Pregnant women or women who are planning to get pregnant
- Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure
- Patients who participated in other clinical studies within the past three months (except for non-interventional observation studies)
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
St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Sung-ho Her, MD.PhD, 821077310052, hhhsungho@naver.com
Jung Jin, MD, 821087238603, colaking@naver.com
About this study
Official title: Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention : A Prospective, Multicenter, Randomized, Open-label Trial
[Purpose of the Clinical Study]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease without percutaneous coronary intervention to confirm non-inferiority in the reduction of key cardiovascular events.
[Hypothesis]:In patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease, low-dose rosuvastatin and ezetimibe combination therapy are non-inferior in terms of reducing major cardiovascular events compared to high-dose rosuvastatin monotherapy.
Read the detailed description
[Background]:While high-dose statin is becoming more important, there are factors that limit more widespread use of such a treatment due to the possibility of adverse events, especially among the patients from East Asia. These factors include muscle-related diseases, higher liver figures, and onset of diabetes. Meanwhile, the combination treatment of low-dose statin and ezetimibe, which slows down the absorption of LDL cholesterol, can see an equivalent level of LDL cholesterol reduction compared to high-dose statin treatments, while having an advantage in terms of the level of decrease in adverse events. However, further verification is still needed whether the statin + ezetimibe combination therapy and the high-dose statin monotherapy of the same reduction effect against LDL cholesterol would have the same level of clinical utility. Especially with regard to the treatment of patients with minimal to minor coronary artery diseases, there are no available guidelines for the use of statin. In the case of a stenosis lesion with a 50 to 70% severity level, the likelihood of choosing medication over percutaneous coronary artery interventions through a physiological evaluation is increasing compared to the past. Also, some studies suggested that the MACE of an intermediate lesion showed a difference depending on the administration of statin, while percutaneous coronary intervention did not. Therefore, verification of the clinical utility on the said lesions is also necessary.
[Clinical Research Plan]: A prospective, multicenter, randomized, and public label clinical study involving a total of 6,356 patients, 3,178 patients each with ezetimibe 10mg/rosuvastatin 5mg (experimental group) and rosuvastatin 20mg (active control group), in patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease. After random assignment, take the assigned drugs for 3 years and follow-up observation is conducted at 6weeks, 6, 12, and 36 months. Test personnel can follow up through hospital visits or phone visits. The primary end-points are a combined assessment variable of all cause death, cardiovascular deaths, myocardial infarction without death, stroke without death, hospitalization due to unstable angina, and revascularization after random assignment at 36 months.
- Conditions
- Coronary Artery Disease, Dyslipidemias, Primary Prevention
- Being tested
- Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg, Mono drug group of Rosuvastatin 20 mg
- Keywords
- Coronary Artery Disease, Dyslipidemias, Primary Prevention
- Medical subject headings
- Coronary Artery Disease, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mgDrug
Oral administration once a day, taking it for 3 years
Mono drug group of Rosuvastatin 20 mgDrug
Oral administration once a day, taking it for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg | Experimental | Ezetimibe 10 mg/Rosuvastatin 5 mg, Oral administration once a day, taking it for 3 years Receives: Drug: Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg |
| Mono drug group of Rosuvastatin 20 mg | Active comparator | Rosuvastatin 20 mg , Oral administration once a day, taking it for 3 years Receives: Drug: Mono drug group of Rosuvastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence rates of the compound variables
The occurrence rates of the compound variables of all cause deaths, cardiac deaths, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, and revascularization after taking the study medicine at the time of Visit 5 (36 month) were compared between groups
Measured: Visit 5 (36month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Feb 2024
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung-ho Her, MD.PhD, Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186037
- Sponsor's protocol ID
- XC23MIDV0033
- Acronym
- ALMIGHTY
- Status last verified
- Feb 2025
- First submitted
- 21 Nov 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention : A Prospective, Multicenter, Randomized, Open-label Trial
- ClinicalTrials.gov ID
- NCT06186037
- Acronym / sponsor ID
- ALMIGHTY / XC23MIDV0033
- Conditions
- Coronary Artery Disease, Dyslipidemias, Primary Prevention
- Keywords
- Coronary Artery Disease, Dyslipidemias, Primary Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,356 participants (estimated)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 29 Dec 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.
[Purpose of the Clinical Study]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease without percutaneous coronary intervention to confirm non-inferiority in the reduction of key cardiovascular events.
[Hypothesis]:In patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease, low-dose rosuvastatin and ezetimibe combination therapy are non-inferior in terms of reducing major cardiovascular events compared to high-dose rosuvastatin monotherapy.
Detailed description
[Background]:While high-dose statin is becoming more important, there are factors that limit more widespread use of such a treatment due to the possibility of adverse events, especially among the patients from East Asia. These factors include muscle-related diseases, higher liver figures, and onset of diabetes. Meanwhile, the combination treatment of low-dose statin and ezetimibe, which slows down the absorption of LDL cholesterol, can see an equivalent level of LDL cholesterol reduction compared to high-dose statin treatments, while having an advantage in terms of the level of decrease in adverse events. However, further verification is still needed whether the statin + ezetimibe combination therapy and the high-dose statin monotherapy of the same reduction effect against LDL cholesterol would have the same level of clinical utility. Especially with regard to the treatment of patients with minimal to minor coronary artery diseases, there are no available guidelines for the use of statin. In the case of a stenosis lesion with a 50 to 70% severity level, the likelihood of choosing medication over percutaneous coronary artery interventions through a physiological evaluation is increasing compared to the past. Also, some studies suggested that the MACE of an intermediate lesion showed a difference depending on the administration of statin, while percutaneous coronary intervention did not. Therefore, verification of the clinical utility on the said lesions is also necessary.
[Clinical Research Plan]: A prospective, multicenter, randomized, and public label clinical study involving a total of 6,356 patients, 3,178 patients each with ezetimibe 10mg/rosuvastatin 5mg (experimental group) and rosuvastatin 20mg (active control group), in patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease. After random assignment, take the assigned drugs for 3 years and follow-up observation is conducted at 6weeks, 6, 12, and 36 months. Test personnel can follow up through hospital visits or phone visits. The primary end-points are a combined assessment variable of all cause death, cardiovascular deaths, myocardial infarction without death, stroke without death, hospitalization due to unstable angina, and revascularization after random assignment at 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg | Experimental | Drug: Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mgEzetimibe 10 mg/Rosuvastatin 5 mg, Oral administration once a day, taking it for 3 years |
| Mono drug group of Rosuvastatin 20 mg | Active comparator | Drug: Mono drug group of Rosuvastatin 20 mgRosuvastatin 20 mg , Oral administration once a day, taking it for 3 years |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female adjusts (19 or older)
- Patients with suspected stable angina pectoris without coronary artery interventions, who showed a minimal to intermediate coronary artery diseases (a stenosis of 10 to 70% diameter as per QCA) in at least one natural coronary artery in coronary artery angiography or coronary artery CT.
- Patients who gave their informed consent themselves in writing.
- Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines.
Key exclusion criteria (12 listed)
- Patients with an intermediate (>30%) lesion on the left main coronary artery.
- Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)
- Patients who received percutaneous coronary intervention
- Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases.
- Patients diagnosed with variant myocardial infarction
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 |
|---|---|---|
| Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mgOral administration once a day, taking it for 3 years | Drug | Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg |
| Mono drug group of Rosuvastatin 20 mgOral administration once a day, taking it for 3 years | Drug | Mono drug group of Rosuvastatin 20 mg |
Primary outcome
The occurrence rates of the compound variables
Time frame: Visit 5 (36month)
The occurrence rates of the compound variables of all cause deaths, cardiac deaths, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, and revascularization after taking the study medicine at the time of Visit 5 (36 month) were compared between groups
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 25 Jun 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.
Sung-ho Her, MD.PhD principal investigator
St Vincent's Hospital
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 Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg and Mono drug group of Rosuvastatin 20 mg in people with Coronary Artery Disease and Dyslipidemias, run by Saint Vincent's Hospital, Korea 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 4 inclusion and 12 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 25 Jun 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 Sung-ho Her, MD.PhD (821077310052, hhhsungho@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence rates of the compound variables (time frame: Visit 5 (36month)). 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 25 Jun 2025.