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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01422421
• Other study ID #: H21-rinsho shiken ippan-017
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 798
• Est. completion date: December 31, 2023
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Myocardial Ischemia
• Type 2 Diabetes

Intervention

Other:
• intensive control
use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
• standard control
use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Locations

Country	Name	City	State
Japan	University Hospital, University of the Ryukyus	Nishihara	Okinawa
Japan	Saga University Hospital	Saga

Sponsors (2)

Lead Sponsor	Collaborator
Takeshi Morimoto	University of the Ryukyus

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite endpoint	composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration	3 years
Primary	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	all-cause mortality	death due to any cause	3 years
Secondary	myocardial infarction	non fatal myocardial infarction	3 years
Secondary	stroke	non fatal stroke excluding transient ischemic attack	3 years
Secondary	Cardiovascular death	Cardiovascular death	3 years
Secondary	end stage renal disease	end stage renal disease needs kidney transplantation or hemodialysis	3 years
Secondary	peripheral artery disease	peripheral artery disease	3 years
Secondary	new onset or deterioration of heart failure	new onset or deterioration of heart failure	3 years