The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.
Prevalence of type 2 diabetes in Asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. Benefit of lowering low density lipoprotein (LDL) cholesterol down to 70 mg/ml in Caucasian patients with coronary artery disease (CAD) has been well established but not in Asian patients with lower risk of myocardial infarction and higher stroke risk. Intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with CAD has been recommended in several guidelines without firm evidence. Risk and benefit of intensive blood pressure and LDL control should be evaluated in Japanese diabetic CAD patients by pragmatic randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
798
use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
University Hospital, University of the Ryukyus
Nishihara, Okinawa, Japan
Saga University Hospital
Saga, Japan
composite endpoint
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration
Time frame: 3 years
important secondary composite endpoint
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure
Time frame: 3 years
all-cause mortality
death due to any cause
Time frame: 3 years
myocardial infarction
non fatal myocardial infarction
Time frame: 3 years
stroke
non fatal stroke excluding transient ischemic attack
Time frame: 3 years
Cardiovascular death
Cardiovascular death
Time frame: 3 years
end stage renal disease
end stage renal disease needs kidney transplantation or hemodialysis
Time frame: 3 years
peripheral artery disease
peripheral artery disease
Time frame: 3 years
new onset or deterioration of heart failure
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new onset or deterioration of heart failure
Time frame: 3 years