Coronary Artery Disease Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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