Coronary Artery Disease, Dyslipidemia, Hypertension, Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, coronary artery disease, hypertension, dyslipidemia
Brief summary
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.
Detailed description
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.
Interventions
OTHERintensive control
use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
OTHERstandard control
use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
Sponsors
Takeshi Morimoto
University of the Ryukyus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome * Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline
Exclusion criteria
* Patients who have active malignant tumor * Patients who are on hemodialysis due to end stage kidney disease * Patients whom statins are contraindicated * Patients who had acute coronary syndrome or stroke within 3 months * Patients who are pregnant or on breast feeding * Patients whose physicians deem that attending this trial is contraindicated or inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite endpoint | 3 years | composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration |
| important secondary composite endpoint | 3 years | composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stroke | 3 years | non fatal stroke excluding transient ischemic attack |
| Cardiovascular death | 3 years | Cardiovascular death |
| all-cause mortality | 3 years | death due to any cause |
| peripheral artery disease | 3 years | peripheral artery disease |
| new onset or deterioration of heart failure | 3 years | new onset or deterioration of heart failure |
| end stage renal disease | 3 years | end stage renal disease needs kidney transplantation or hemodialysis |
| myocardial infarction | 3 years | non fatal myocardial infarction |
Countries
Japan
Outcome results
None listed