Coronary Artery Disease
Conditions
Keywords
Pitavastatin, Coronary Artery Disease, Cardiovascular Disease
Brief summary
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.
Detailed 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.
Interventions
Patients who met all inclusion criteria and did not meet exclusion criteria (1) are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (Primary registration) After 1 month, patients who did not meet exclusion criteria(2) are randomized to take pitavastatin 1 mg/day or 4 mg/day.
Sponsors
Tokyo University
Yamaguchi University Hospital
Tohoku University
Kyoto University
Kumamoto University
Juntendo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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 * History of Acute Coronary Syndrome (AMI or Unstable angina) * History of revascularization (PCI or CABG) * Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification * Hypercholesterolemia patients meeting one of following criteria * LDL-C is 140 mg/dL or over * LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians * Patents receiving cholesterol lowering drugs * Age (≧20 \<80 year-old) * Patients given written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of one of following events(Cardiovascular death, Non-fatal Myocardial Infarction (MI), Non-fatal Cerebral Infarction (CI), Unstable angina requiring urgent hospitalization) | 3-6 years |
Secondary
| Measure | Time frame |
|---|---|
| Cerebrovascular events | 3-6 years |
| The other events | 3-6 years |
| Composite cardiovascular events | 3-6 years |
| Heart disease events | 3-6 years |
| Composite cerebrovascular events | 3-6 years |
| Death events | 3-6 years |
| Composite coronary heart disease events | 3-6 years |
Countries
Japan
Outcome results
None listed