A Phase 4 interventional study of Rosuvastatin 5mg and Rosuvastatin 20mg in Coronary Artery Disease, Coronary Disease and Cardiovascular Diseases, sponsored by Korea University Anam Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2016-08-09.
Sponsored by Korea University Anam Hospital · Phase 4, Interventional, and Treatment
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.
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.
4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are treated with Rosuvastatin 5mg/day for 30 months after percutaneous coronary intervention
Drug: Rosuvastatin 5mg
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
Also known as: Low dose group
Rosuvastatin 5mg tablet, q.d., for 30 months
Also known as: Hihg dose group
Major adverse cardiovascular outcome
The cumulative incidences of the composite events of cardiac death, myocardial infarction, and repeat revascularization
Time frame: Baseline to Final visit (30 months)
All-cause death
The cumulative incidences of all-cause death for 30 months after percutaneous coronary intervention with drug-eluting stent
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 6 months of treatment and thereafter
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Korea University Anam Hospital