Atherosclerotic Cardiovascular DiseasePhase 4MIRANCT03597412
Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM
A Phase 4 study testing Rosuvamibe and Monorova in people with Atherosclerotic Cardiovascular Disease and Type 2 Diabetes Mellitus, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Type 2 Diabetes Mellitus
- What is being tested?
- Rosuvamibe and Monorova
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2018to 12 Aug 2020
- 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 and above
- Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
- Patient diagnosed with ASCVD
- Myocardial Infarction (MI)
- Acute coronary syndrome (ACS)
- History of Coronary revascularization(Percutaneous Coronary Intervention, PCI)
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- History of Coronary artery bypass graft surgery (CABG) or other arterial revascularization procedures
- Stroke or Transient ischemic attack (TIA)
- Peripheral Arterial Disease (PAD)
- Stable Angina
- Written informed consent
Who cannot join
- Type 1 diabetes
- HbA1c > 8.5% at screening
- Fasting triglyceride ≥ 400 mg/dL at screening
- History of muscular disease or rhabdomyolysis due to use of statin
- Hypersensitive to rosuvastatin or ezetemibe
- Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:
Show all 11Show fewer
- ① Severe renal disease (CrCL < 30mL/min: Cockcroft-gault formula or estimated GFR (MDRD) < 30mL/min/1.73m2)
- ② ALT, AST > 3x ULN or history of active liver disease
- ③ CPK > 3x ULN
- Those participating in clinical trials of other drugs
- Other than the above who is deemed to be ineligible to participate in the trial by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Type 2 Diabetes Mellitus (DM)
This study will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus
- Being tested
- Rosuvamibe, Monorova
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvamibeDrug
Rosuvastatin 10mg/Ezetimibe 10mg
MonorovaDrug
Rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| Rosuvamibe Tab | Experimental | Rosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks Receives: Drug: Rosuvamibe |
| Monorova Tab | Active comparator | Rosuvastatin 20mg qd for 24 weeks Receives: Drug: Monorova |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 24 in LDL-C level
Measured: Baseline, Week 24
Secondary outcomes (10)
Change from baseline to week 12 in LDL-C level
Measured: Baseline, Week 12
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1
Measured: Baseline, Week 24
Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Measured: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Measured: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL
Measured: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 55mg/dL
Measured: Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start17 Oct 2018
- Primary completion12 Aug 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies 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
- 236 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
- NCT03597412
- Sponsor's protocol ID
- YMC038
- Acronym
- MIRA
- Status last verified
- Dec 2020
- First submitted
- 13 Jul 2018
- Last updated
- 14 Dec 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 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy Versus Rosuvastatin Monotherapy in Atherosclerotic Cardiovascular Disease (ASCVD) Patients With Type 2 Diabetes Mellitus (DM)
- ClinicalTrials.gov ID
- NCT03597412
- Acronym / sponsor ID
- MIRA / YMC038
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 24 Jul 2018 (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 will evaluate the efficacy and aafety of rosuvastatin/ezetimibe combination therapy vs. rosuvastatin monotherapy in atherosclerotic cardiovascular disease patients with type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvamibe Tab | Experimental | Drug: RosuvamibeRosuvastatin 10mg/Ezetimibe 10mg qd for 24 weeks |
| Monorova Tab | Active comparator | Drug: MonorovaRosuvastatin 20mg qd for 24 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 19 and above
- Patient with type 2 diabetes taking oral diabetes medication for at least 3 months
- Patient diagnosed with ASCVD
- Written informed consent
Key exclusion criteria (11 listed)
- Type 1 diabetes
- HbA1c > 8.5% at screening
- Fasting triglyceride ≥ 400 mg/dL at screening
- History of muscular disease or rhabdomyolysis due to use of statin
- Hypersensitive to rosuvastatin or ezetemibe
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 |
|---|---|---|
| RosuvamibeRosuvastatin 10mg/Ezetimibe 10mg | Drug | Rosuvamibe Tab |
| MonorovaRosuvastatin 20mg | Drug | Monorova Tab |
Primary outcome
Change from baseline to week 24 in LDL-C level
Time frame: Baseline, Week 24
10 secondary outcomes
Change from baseline to week 12 in LDL-C level
Time frame: Baseline, Week 12
Change from baseline to week 12 and week 24 in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein B48, and Apolipoprotein B/Apolipoprotein A1
Time frame: Baseline, Week 24
Change from baseline to week 12 and week 24 in glycosylated hemoglobin (HbA1c)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in fasting plasma glucose (FPG)
Time frame: Baseline, Week 12, Week 24
Change from baseline to week 12 and week 24 in homeostasis model assessment for insulin resistance (HOMA-IR)
Time frame: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 70mg/dL
Time frame: Baseline, Week 12, Week 24
Proportion of subjects achieving LDL-C < 55mg/dL
Time frame: Baseline, Week 12, Week 24
Occurrence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Event)
Time frame: Up to 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 14 Dec 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.
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 Rosuvamibe and Monorova in people with Atherosclerotic Cardiovascular Disease and Type 2 Diabetes Mellitus, run by Yuhan Corporation 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 11 inclusion and 11 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 14 Dec 2020. 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?
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 from baseline to week 24 in LDL-C level (time frame: Baseline, Week 24). 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 Dec 2020.