NCT01422421

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

Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 798 (actual)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Coronary Artery Disease
• Hypertension
• Dyslipidemia

Interventions

Type	Name	Description
OTHER	intensive control	use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
OTHER	standard control	use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Timeline

• Start date: 2011-08-01
• Primary completion: 2022-03-31
• Completion: 2023-12-31
• First posted: 2011-08-24
• Last updated: 2024-06-14

Locations

2 sites across 1 country: Japan