Clinical trial NCT02859480: Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Coronary Disease
Cardiovascular Diseases
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
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Samjin Pharmaceutical Co., Ltd.
First posted: 2016-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Major adverse cardiovascular outcome
timeFrame: Baseline to Final visit (30 months)
Secondary outcomes:
measure: All-cause death
timeFrame: Baseline to Final visit (30 months)
measure: Cardiac death
timeFrame: Baseline to Final visit (30 months)
measure: Non-fatal myocardial infarction
timeFrame: Baseline to Final visit (30 months)
measure: Repeat revascularization
timeFrame: Baseline to Final visit (30 months)
measure: Stent thrombosis
timeFrame: Baseline to Final visit (30 months)
measure: Target LDL-C level achievement
timeFrame: 6 months of treatment and thereafter
measure: LDL-C level change
timeFrame: Baseline to 6 months of treatment and thereafter
measure: HDL-C level change
timeFrame: Baseline to 6 months of treatment and thereafter
measure: Level change of other biomarkers
timeFrame: Baseline to 6 months of treatment and thereafter
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Department of Cardiology, Korea University Anam Hospital
name: Hyung Joon Joo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Korea University Anam Hospital
name: Do-sun Lim, MD, PhD
role: STUDY_CHAIR
References: