Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease

Takeshi Morimoto

Status and phase: Completed; Phase 4

Conditions: Hypertension; Coronary Artery Disease; Dyslipidemia; Type 2 Diabetes

Treatments: Other: intensive control; Other: standard control

Study type: Interventional

Funder types: Other

Identifiers

NCT01422421

H21-rinsho shiken ippan-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 798 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

798 participants in 2 patient groups

intensive control

Active Comparator group

Description:

systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl

Treatment:

Other: intensive control

standard control

Active Comparator group

Description:

systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Treatment:

Other: standard control