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

Phase 4

Completed

• Conditions: Hypertension; Coronary Artery Disease; Dyslipidemia; Type 2 Diabetes
• Interventions: Other: standard control; Other: intensive control

• Registration Number: NCT01422421
• Lead Sponsor: Takeshi Morimoto

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Primary Completion: 2022-03-31
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 798

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard control	standard control	systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
intensive control	intensive control	systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Saga University Hospital; 🇯🇵 Saga, Japan

University Hospital, University of the Ryukyus; 🇯🇵 Nishihara, Okinawa, Japan