ROSUVA-30: Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rosuvastatin 5mg Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention |
Drug: Rosuvastatin 5mg
Rosuvastatin 5mg tablet, q.d., for 30 months
Other Names:
|
| Active Comparator: Rosuvastatin 20mg Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention |
Drug: Rosuvastatin 20mg
Rosuvastatin 5mg tablet, q.d., for 30 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Major adverse cardiovascular outcome [Baseline to Final visit (30 months)]
The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization
Secondary Outcome Measures
- All-cause death [Baseline to Final visit (30 months)]
The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent
- Cardiac death [Baseline to Final visit (30 months)]
The cumulative incidences of cardiac death for 30 months after percutaneous coronary intervention with drug-eluting stent
- Non-fatal myocardial infarction [Baseline to Final visit (30 months)]
The cumulative incidences of non-fatal myocardial infarction for 30 months after percutaneous coronary intervention with drug-eluting stent
- Repeat revascularization [Baseline to Final visit (30 months)]
The cumulative incidences of any repeat coronary revascularization for 30 months after percutaneous coronary intervention with drug-eluting stent
- Stent thrombosis [Baseline to Final visit (30 months)]
The cumulative incidences of stent thrombosis categorized by ARC criteria for 30 months after percutaneous coronary intervention with drug-eluting stent
- Target LDL-C level achievement [6 months of treatment and thereafter]
The percentage of the participants who reached the LDL-C level of <70mg/dL after the treatment for 6 months.
- LDL-C level change [Baseline to 6 months of treatment and thereafter]
The percent changes of LDL-C level from baseline to to 6 months of treatment and thereafter
- HDL-C level change [Baseline to 6 months of treatment and thereafter]
The percent changes of HDL-C level from baseline to to 6 months of treatment and thereafter
- Level change of other biomarkers [Baseline to 6 months of treatment and thereafter]
The percent changes of serum level of other biomarkers from baseline to to 6 months of treatment and thereafter
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients underwent percutaneous coronary intervention with drug-eluting stent;
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 |
Sponsors and Collaborators
- Korea University Anam Hospital
- Samjin Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Hyung Joon Joo, MD, PhD, Department of Cardiology, Korea University Anam Hospital
- Study Chair: Do-sun Lim, MD, PhD, Department of Cardiology, Korea University Anam Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ED15175