Coronary Artery DiseasePhase 4ROSUVA-30NCT02859480
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
A Phase 4 study testing Rosuvastatin 5mg and Rosuvastatin 20mg in people with Coronary Artery Disease and Coronary Disease, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases
- What is being tested?
- Rosuvastatin 5mg and Rosuvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Dec 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent percutaneous coronary intervention with drug-eluting stent;
Who cannot join
- Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates;
- Serum creatinine level > 2.0 mg/dL
- Serum aspartate transaminase > 3 times upper limit of normal
- Serum alanine transaminase > 3 times upper limit of normal
- Having anaphylactic reaction for Rosuvastatin;
- Having the other contraindications for Rosuvastatin;
- Having plan to be pregnant;
- Having life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Hyung Joon Joo, MD, PhD, +8229205445, drjoohj@gmail.com
About this study
Official title: Effectiveness and Safety of Low-dose vs. High-dose Rosuvastatin on Long-term Cardiovascular Events in Korean Patients After Percutaneous Coronary Intervention: 30-month, Prospective, Single-center, Randomized Trial
This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.
Read the detailed description
With the development of the newer generation drug-eluting stents, percutaneous coronary intervention (PCI) has been a feasible treatment for patient with coronary artery disease. However, stent failures including in-stent restenosis and stent thrombosis have been still problematic. Moreover, neoatherosclerosis, which is the atherosclerotic process developed in the neointima within the implanted stent, has been reported to be associated with neoatherosclerotic plaque rupture and contribute to the development of acute coronary syndrome in patients after drug-eluting stent (DES) implantation.
In this perspective, recent AHA/ACC and ESC guidelines recommend the high-dose(intensity) statin therapy for patients performed PCI. However, the efficacy of the high-dose(intensity) statin therapy on cardiovascular outcomes is still controversial. Several meta-analysis failed to show the benefit of the high-dose(intensity) statin therapy to reduce the mortality. Moreover, clear evidence for the benefits of such high-dose(intensity) statin therapy has no yet been demonstrated in East Asian patients.
This trial was designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after PCI in the era of the newer generation DES era.
- Being tested
- Rosuvastatin 5mg, Rosuvastatin 20mg
- Keywords
- Rosuvastatin Calcium, Percutaneous Coronary Intervention, Drug-Eluting Stents, Patient Outcome Assessment, Biomarkers, Hyperlipidemias, Dyslipidemias, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Anticholesteremic Agents, Hypolipidemic Agents, Lipid Regulating Agents
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases, Hyperlipidemias, Dyslipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 5mgDrug
Also called Low dose group
Rosuvastatin 5mg tablet, q.d., for 30 months
Rosuvastatin 20mgDrug
Also called Hihg dose group
Rosuvastatin 5mg tablet, q.d., for 30 months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 5mg | Experimental | Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention Receives: Drug: Rosuvastatin 5mg |
| Rosuvastatin 20mg | Active comparator | Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention Receives: Drug: Rosuvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular outcome
The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization
Measured: Baseline to Final visit (30 months)
Secondary outcomes (9)
All-cause death
The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent
Measured: Baseline to Final visit (30 months)
Cardiac death
The cumulative incidences of cardiac death for 30 months after percutaneous coronary intervention with drug-eluting stent
Measured: Baseline to Final visit (30 months)
Non-fatal myocardial infarction
The cumulative incidences of non-fatal myocardial infarction for 30 months after percutaneous coronary intervention with drug-eluting stent
Measured: Baseline to Final visit (30 months)
Repeat revascularization
The cumulative incidences of any repeat coronary revascularization for 30 months after percutaneous coronary intervention with drug-eluting stent
Measured: Baseline to Final visit (30 months)
Stent thrombosis
The cumulative incidences of stent thrombosis categorized by ARC criteria for 30 months after percutaneous coronary intervention with drug-eluting stent
Measured: Baseline to Final visit (30 months)
Target LDL-C level achievement
The percentage of the participants who reached the LDL-C level of <70mg/dL after the treatment for 6 months.
Measured: 6 months of treatment and thereafter
LDL-C level change
The percent changes of LDL-C level from baseline to to 6 months of treatment and thereafter
Measured: Baseline to 6 months of treatment and thereafter
HDL-C level change
The percent changes of HDL-C level from baseline to to 6 months of treatment and thereafter
Measured: Baseline to 6 months of treatment and thereafter
Level change of other biomarkers
The percent changes of serum level of other biomarkers from baseline to to 6 months of treatment and thereafter
Measured: Baseline to 6 months of treatment and thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Hyung Joon Joo, Korea University Anam Hospital
- Investigators
- Hyung Joon Joo, MD, PhD, Principal investigator, Department of Cardiology, Korea University Anam HospitalDo-sun Lim, MD, PhD, Study chair, Department of Cardiology, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859480
- Sponsor's protocol ID
- ED15175
- Acronym
- ROSUVA-30
- Status last verified
- Aug 2016
- First submitted
- 4 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Low-dose vs. High-dose Rosuvastatin on Long-term Cardiovascular Events in Korean Patients After Percutaneous Coronary Intervention: 30-month, Prospective, Single-center, Randomized Trial
- ClinicalTrials.gov ID
- NCT02859480
- Acronym / sponsor ID
- ROSUVA-30 / ED15175
- Keywords
- Rosuvastatin Calcium, Percutaneous Coronary Intervention, Drug-Eluting Stents, Patient Outcome Assessment, Biomarkers, Hyperlipidemias, Dyslipidemias, Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd.
- Study start
- Sep 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- 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 prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.
Detailed description
With the development of the newer generation drug-eluting stents, percutaneous coronary intervention (PCI) has been a feasible treatment for patient with coronary artery disease. However, stent failures including in-stent restenosis and stent thrombosis have been still problematic. Moreover, neoatherosclerosis, which is the atherosclerotic process developed in the neointima within the implanted stent, has been reported to be associated with neoatherosclerotic plaque rupture and contribute to the development of acute coronary syndrome in patients after drug-eluting stent (DES) implantation.
In this perspective, recent AHA/ACC and ESC guidelines recommend the high-dose(intensity) statin therapy for patients performed PCI. However, the efficacy of the high-dose(intensity) statin therapy on cardiovascular outcomes is still controversial. Several meta-analysis failed to show the benefit of the high-dose(intensity) statin therapy to reduce the mortality. Moreover, clear evidence for the benefits of such high-dose(intensity) statin therapy has no yet been demonstrated in East Asian patients.
This trial was designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after PCI in the era of the newer generation DES era.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 5mg | Experimental | Drug: Rosuvastatin 5mgPatients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention |
| Rosuvastatin 20mg | Active comparator | Drug: Rosuvastatin 20mgPatients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent percutaneous coronary intervention with drug-eluting stent;
Key exclusion criteria (8 listed)
- Taking other drugs which can influence the lipid profile (eg. Niacin, Fibrates;
- Serum creatinine level > 2.0 mg/dL
- Serum aspartate transaminase > 3 times upper limit of normal
- Serum alanine transaminase > 3 times upper limit of normal
- Having anaphylactic reaction for Rosuvastatin;
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 |
|---|---|---|
| Rosuvastatin 5mgAlso: Low dose groupRosuvastatin 5mg tablet, q.d., for 30 months | Drug | Rosuvastatin 5mg |
| Rosuvastatin 20mgAlso: Hihg dose groupRosuvastatin 5mg tablet, q.d., for 30 months | Drug | Rosuvastatin 20mg |
Primary outcome
Major adverse cardiovascular outcome
Time frame: Baseline to Final visit (30 months)
The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization
9 secondary outcomes
All-cause death
Time frame: Baseline to Final visit (30 months)
Cardiac death
Time frame: Baseline to Final visit (30 months)
Non-fatal myocardial infarction
Time frame: Baseline to Final visit (30 months)
Repeat revascularization
Time frame: Baseline to Final visit (30 months)
Stent thrombosis
Time frame: Baseline to Final visit (30 months)
Target LDL-C level achievement
Time frame: 6 months of treatment and thereafter
LDL-C level change
Time frame: Baseline to 6 months of treatment and thereafter
HDL-C level change
Time frame: Baseline to 6 months of treatment and thereafter
Level change of other biomarkers
Time frame: Baseline to 6 months of treatment and thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- 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.
Hyung Joon Joo, MD, PhD principal investigator
Department of Cardiology, Korea University Anam Hospital
Do-sun Lim, MD, PhD study chair
Department of Cardiology, Korea University Anam 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 Rosuvastatin 5mg and Rosuvastatin 20mg in people with Coronary Artery Disease and Coronary Disease, run by Korea University Anam Hospital 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyung Joon Joo, MD, PhD (+8229205445, drjoohj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular outcome (time frame: Baseline to Final visit (30 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 9 Aug 2016.