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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetes Coronary Artery Disease Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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intensive control

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

Group Type ACTIVE_COMPARATOR

intensive control

Intervention Type OTHER

use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl

standard control

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

Group Type ACTIVE_COMPARATOR

standard control

Intervention Type OTHER

use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Interventions

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intensive control

use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl

Intervention Type OTHER

standard control

use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No