Acute Coronary SyndromePhase 4NCT04056169
Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
A Phase 4 study testing high-dose rosuvastatin and low-dose rosuvastatin plus ezetimibe in people with Acute Coronary Syndrome and Carotid Atherosclerotic Plaque With Inflammation, run by Yuhan Corporation at 2 sites in South Korea.
Trial summary
Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Carotid Atherosclerotic Plaque With Inflammation
- What is being tested?
- high-dose rosuvastatin and low-dose rosuvastatin plus ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 29 Jun 2017to 23 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- aged ≥ 19 years
- acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging
- written consent
Who cannot join
- previous history of carotid endarterectomy or stenting
- schedule for cardiac or major surgery within the next 6 months
- statin or ezetimibe therapy in the past 4 weeks
- chronic disease needed to be treated with oral, intravenous, or intraarticular steroid
- end-stage renal disease
- chronic liver disease
Show all 9Show fewer
- history of cancers within the past 3 years
- pregnant, breast-feeding or child-bearing potential
- expected life expectancy within 2 years
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul
Korea University Guro Hospital
Seoul
About this study
Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by >50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.
- Being tested
- high-dose rosuvastatin, low-dose rosuvastatin plus ezetimibe
- Keywords
- rosuvastatin, ezetimibe/rosuvastatin, carotid plaque inflammation, fluorodeoxyglucose F18, positron emission tomography
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose rosuvastatinDrug
rosuvastatin 20 mg once a day for 6 months
low-dose rosuvastatin plus ezetimibeDrug
ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Active comparator | rosuvastatin 20 mg once a day for 6 months Receives: Drug: high-dose rosuvastatin |
| ezetimibe/rosuvastatin | Experimental | ezetimibe/rosuvastatin 10/5 mg once a day for 6 months Receives: Drug: low-dose rosuvastatin plus ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
Measured: 6 months
Secondary outcomes (8)
Change in MDS TBR
Measured: 6 months
Change in whole vessel TBR within the index vessel
Measured: 6 months
Change in whole vessel TBR of the aorta
Measured: 6 months
Change in total cholesterol
Measured: 6 months
Change in triglyceride
Measured: 6 months
Change in HDL-cholesterol
Measured: 6 months
Change in LDL-cholesterol
Measured: 6 months
Change in high sensitive C-reactive protein
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start29 Jun 2017
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056169
- Sponsor's protocol ID
- seeCAP
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 16 Aug 2019
- 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 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04056169
- Acronym / sponsor ID
- seeCAP
- Keywords
- rosuvastatin, ezetimibe/rosuvastatin, carotid plaque inflammation, fluorodeoxyglucose F18, positron emission tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 14 Aug 2019 (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.
Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by >50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Active comparator | Drug: high-dose rosuvastatinrosuvastatin 20 mg once a day for 6 months |
| ezetimibe/rosuvastatin | Experimental | Drug: low-dose rosuvastatin plus ezetimibeezetimibe/rosuvastatin 10/5 mg once a day for 6 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 19 years
- acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging
- written consent
Key exclusion criteria (9 listed)
- previous history of carotid endarterectomy or stenting
- schedule for cardiac or major surgery within the next 6 months
- statin or ezetimibe therapy in the past 4 weeks
- chronic disease needed to be treated with oral, intravenous, or intraarticular steroid
- end-stage renal disease
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 |
|---|---|---|
| high-dose rosuvastatinrosuvastatin 20 mg once a day for 6 months | Drug | Rosuvastatin |
| low-dose rosuvastatin plus ezetimibeezetimibe/rosuvastatin 10/5 mg once a day for 6 months | Drug | ezetimibe/rosuvastatin |
Primary outcome
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel
Time frame: 6 months
8 secondary outcomes
Change in MDS TBR
Time frame: 6 months
Change in whole vessel TBR within the index vessel
Time frame: 6 months
Change in whole vessel TBR of the aorta
Time frame: 6 months
Change in total cholesterol
Time frame: 6 months
Change in triglyceride
Time frame: 6 months
Change in HDL-cholesterol
Time frame: 6 months
Change in LDL-cholesterol
Time frame: 6 months
Change in high sensitive C-reactive protein
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing high-dose rosuvastatin and low-dose rosuvastatin plus ezetimibe in people with Acute Coronary Syndrome and Carotid Atherosclerotic Plaque With Inflammation, run by Yuhan Corporation at 2 sites 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 9 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: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel (time frame: 6 months). 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 16 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.