Status
Conditions
Treatments
About
The purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.
Full description
It was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. However, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in Japan.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration)
Coronary artery disease patients meeting one of the following events
Hypercholesterolemia patients meeting one of following criteria
Age (≧20 <80 year-old)
Patients given written informed consent.
Exclusion criteria
Exclusion Criteria(Pre-Run-in period)
Patients planning revascularization
Malignant tumor in active phase
Patients who meet contraindication of LIVALO tablet below
Patients who have heart failure NYHA III or greater
Patients undergoing dialysis
Patients with familial hypercholesterolemia
Patients registered in the other clinical trials
Patients taking prohibited drugs
Patients who are ineligible in the opinion of the investigator
Exclusion Criteria(Post-Run-in period)
Primary purpose
Allocation
Interventional model
Masking
13,054 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal