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

Primary Purpose

Type 2 Diabetes, Coronary Artery Disease, Hypertension

Status
Active
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
intensive control
standard control
Sponsored by
Takeshi Morimoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring type 2 diabetes, coronary artery disease, hypertension, dyslipidemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, University of the Ryukyus
  • Saga University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

intensive control

standard control

Arm Description

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

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

Outcomes

Primary Outcome Measures

composite endpoint
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration
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

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2011
Last Updated
April 3, 2023
Sponsor
Takeshi Morimoto
Collaborators
University of the Ryukyus
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1. Study Identification

Unique Protocol Identification Number
NCT01422421
Brief Title
Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease
Official Title
Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto
Collaborators
University of the Ryukyus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Coronary Artery Disease, Hypertension, Dyslipidemia
Keywords
type 2 diabetes, coronary artery disease, hypertension, dyslipidemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
798 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive control
Arm Type
Active Comparator
Arm Description
systolic blood pressure less than 120mmHg and LDL cholesterol within 70- 85mg/dl
Arm Title
standard control
Arm Type
Active Comparator
Arm Description
systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
Intervention Type
Other
Intervention Name(s)
intensive control
Intervention Description
use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
Intervention Type
Other
Intervention Name(s)
standard control
Intervention Description
use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
Primary Outcome Measure Information:
Title
composite endpoint
Description
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration
Time Frame
3 years
Title
important secondary composite endpoint
Description
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure
Time Frame
3 years
Secondary Outcome Measure Information:
Title
all-cause mortality
Description
death due to any cause
Time Frame
3 years
Title
myocardial infarction
Description
non fatal myocardial infarction
Time Frame
3 years
Title
stroke
Description
non fatal stroke excluding transient ischemic attack
Time Frame
3 years
Title
Cardiovascular death
Description
Cardiovascular death
Time Frame
3 years
Title
end stage renal disease
Description
end stage renal disease needs kidney transplantation or hemodialysis
Time Frame
3 years
Title
peripheral artery disease
Description
peripheral artery disease
Time Frame
3 years
Title
new onset or deterioration of heart failure
Description
new onset or deterioration of heart failure
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichiro Ueda, MD, PhD
Organizational Affiliation
Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, University of the Ryukyus
City
Nishihara
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan

12. IPD Sharing Statement

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

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