Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Rosuvastatin 5mg
* Drug: Rosuvastatin 20mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin 5mg<br>Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention | Drug: Rosuvastatin 5mg<br>* Rosuvastatin 5mg tablet, q.d., for 30 months<br>* Other names: Low dose group;|
| Active Comparator: Rosuvastatin 20mg<br>Patients are treated with Rosuvastatin 20mg/day for 30 months after percutaneous coronary intervention | Drug: Rosuvastatin 20mg<br>* Rosuvastatin 5mg tablet, q.d., for 30 months<br>* Other names: Hihg dose group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular outcome | The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization | Baseline to Final visit (30 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | Baseline to 6 months of treatment and thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypolipidemic Agents, Rosuvastatin Calcium, Percutaneous Coronary Intervention, Drug-Eluting Stents, Patient Outcome Assessment, Biomarkers, Hyperlipidemias, Dyslipidemias, Atherosclerosis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Anticholesteremic Agents, Lipid Regulating Agents