Cardiovascular DiseasesPhase 4NCT04080310
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin
A Phase 4 study testing Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin in people with Cardiovascular Diseases, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
Trial summary
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Mar 2018to 17 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 19 and 75 years
- Presence of atherosclerotic cardiovascular disease Coronary artery disease
- History of acute coronary syndrome
- Stable or unstable angina
- History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization
- Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
- Patients who gave informed consent
Who cannot join
- Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
- A serum triglyceride on fasting >400 mg/dL
- A history of muscular symptoms or rhabdomyolysis due to the use of statin
- Hypersensitivity to rosuvastatin or ezetimibe
- Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl <30 mL/min by Cockcroft-Gault formula or estimated GFR <30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
- Enrollment of other clinical trials within 30 days
- Any other issues that the treating physician assumes ineligible for participation in the trial
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 06511
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin: Study Protocol for a Randomized Controlled Trial
This study is a multicenter, randomized, open-label, parallel, phase IV trial.
The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.
Read the detailed description
The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.
The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.
- Conditions
- Cardiovascular Diseases
- Being tested
- Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statinDrug
This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.
| Study group | Role | What they receive |
|---|---|---|
| combination therapy group | Active comparator | The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily. Receives: Drug: Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin |
| intensive statin group | Other | The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily. Receives: Drug: Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change of low-density lipoprotein cholesterol
%change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline * 100
Measured: at 12 weeks
Secondary outcomes (8)
% change of serum cholesterol level
total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL)
Measured: at 12 and 24 weeks
% change of high-sensitivity C-reactive protein
hs-CRP(mg/dL)
Measured: at 12 and 24 weeks
% change of fasting glucose
fasting plasma glucose(mg/dL)
Measured: at 12 and 24 weeks
% change of homeostatic model assessment for insulin resistance(HOMA-IR)
HOMA-IR = glucose * insulin / 405(glucose mg/dL , insulin uIU/mL)
Measured: at 12 and 24 weeks
proportion of participant with statin-associated muscle symptoms
occurrence of statin-associated muscle symptoms
Measured: at 12 and 24 weeks
proportion of participant with creatinine phosphokinase elevation
proportion of CPK elevation ≥4 or ≥10 upper normal of limit
Measured: at 12 and 24 weeks
proportion of participant with liver function test abnormality
proportion of AST/ALT elevation ≥4 or ≥10 upper normal of limit
Measured: at 12 and 24 weeks
proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)
MACCE defined as a composite of the followings : cardiovascular death, acute myocardial infarction, unstable angina, stroke
Measured: at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Mar 2018
- Primary completion15 Jun 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yuhan Corporation
- Responsible party
- Principal investigator, Si-Hyuck Kang, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080310
- Sponsor's protocol ID
- YMC033
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2019
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04080310
- Acronym / sponsor ID
- YMC033
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Yuhan Corporation
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 6 Sep 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.
This study is a multicenter, randomized, open-label, parallel, phase IV trial.
The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.
Detailed description
The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.
The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.
Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.
The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy group | Active comparator | Drug: Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statinThe combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily. |
| intensive statin group | Other | Drug: Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statinThe subjects in the intensive statin group will receive rosuvastatin 20 mg once daily. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 19 and 75 years
- Presence of atherosclerotic cardiovascular disease Coronary artery disease
- Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
- Patients who gave informed consent
Key exclusion criteria (7 listed)
- Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
- A serum triglyceride on fasting >400 mg/dL
- A history of muscular symptoms or rhabdomyolysis due to the use of statin
- Hypersensitivity to rosuvastatin or ezetimibe
- Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl <30 mL/min by Cockcroft-Gault formula or estimated GFR <30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
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 |
|---|---|---|
| Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statinThis study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy. After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily. | Drug | combination therapy group, intensive statin group |
Primary outcome
% change of low-density lipoprotein cholesterol
Time frame: at 12 weeks
%change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline * 100
8 secondary outcomes
% change of serum cholesterol level
Time frame: at 12 and 24 weeks
% change of high-sensitivity C-reactive protein
Time frame: at 12 and 24 weeks
% change of fasting glucose
Time frame: at 12 and 24 weeks
% change of homeostatic model assessment for insulin resistance(HOMA-IR)
Time frame: at 12 and 24 weeks
proportion of participant with statin-associated muscle symptoms
Time frame: at 12 and 24 weeks
proportion of participant with creatinine phosphokinase elevation
Time frame: at 12 and 24 weeks
proportion of participant with liver function test abnormality
Time frame: at 12 and 24 weeks
proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)
Time frame: at 12 and 24 weeks
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 20 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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. 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 Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin in people with Cardiovascular Diseases, run by Seoul National University Bundang Hospital 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 7 inclusion and 7 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 20 Mar 2020. 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?
% change of low-density lipoprotein cholesterol (time frame: at 12 weeks). 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 20 Mar 2020.