Clinical trial NCT01422421: Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease
Official title: Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Coronary Artery Disease
Hypertension
Dyslipidemia
Keywords: type 2 diabetes
coronary artery disease
hypertension
dyslipidemia
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: University of the Ryukyus
First posted: 2011-08-24
Enrollment: 798
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite endpoint
timeFrame: 3 years
measure: important secondary composite endpoint
timeFrame: 3 years
Secondary outcomes:
measure: all-cause mortality
timeFrame: 3 years
measure: myocardial infarction
timeFrame: 3 years
measure: stroke
timeFrame: 3 years
measure: Cardiovascular death
timeFrame: 3 years
measure: end stage renal disease
timeFrame: 3 years
measure: peripheral artery disease
timeFrame: 3 years
measure: new onset or deterioration of heart failure
timeFrame: 3 years
Other outcomes:
Locations:
city: Nishihara
country: Japan
facility: University Hospital, University of the Ryukyus
state: Okinawa
city: Saga
country: Japan
facility: Saga University Hospital
Study officials:
affiliation: Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus
name: Shinichiro Ueda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: