Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases
Conditions
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
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.
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.
Interventions
DRUGRosuvastatin 5mg
Rosuvastatin 5mg tablet, q.d., for 30 months
DRUGRosuvastatin 20mg
Rosuvastatin 5mg tablet, q.d., for 30 months
Sponsors
Samjin Pharmaceutical Co., Ltd.
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
Countries
South Korea
Contacts
Primary ContactHyung Joon Joo, MD, PhD
Outcome results
None listed