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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Hypertension; Type 2 Diabetes; Dyslipidemia
• Intervention / Treatment: Other: intensive control; Other: standard control

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.

• Study Type: Interventional
• Enrollment (Actual): 798
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Okinawa
    • Nishihara, Okinawa, Japan, 903-0215
      • University Hospital, University of the Ryukyus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intensive control; systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl	Other: intensive control; use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
Active Comparator: standard control; systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl	Other: standard control; use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite endpoint	composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration	3 years
important secondary composite endpoint	composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	death due to any cause	3 years
myocardial infarction	non fatal myocardial infarction	3 years
stroke	non fatal stroke excluding transient ischemic attack	3 years
Cardiovascular death	Cardiovascular death	3 years
end stage renal disease	end stage renal disease needs kidney transplantation or hemodialysis	3 years
peripheral artery disease	peripheral artery disease	3 years
new onset or deterioration of heart failure	new onset or deterioration of heart failure	3 years

Collaborators and Investigators

• Sponsor: Takeshi Morimoto
• Collaborators: University of the Ryukyus
• Investigators: Principal Investigator: Shinichiro Ueda, MD, PhD, Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (Estimated): August 24, 2011

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: coronary artery disease; hypertension; type 2 diabetes; dyslipidemia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: H21-rinsho shiken ippan-017