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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Collaborator:
University of the Ryukyus
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01422421
First received: August 23, 2011
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Coronary Artery Disease
Hypertension
Dyslipidemia
Other: intensive control
Other: standard control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • composite endpoint [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration


Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    death due to any cause

  • myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    non fatal myocardial infarction

  • stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    non fatal stroke excluding transient ischemic attack

  • Cardiovascular death [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cardiovascular death

  • end stage renal disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    end stage renal disease needs kidney transplantation or hemodialysis

  • peripheral artery disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    peripheral artery disease

  • new onset or deterioration of heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    new onset or deterioration of heart failure


Estimated Enrollment: 1000
Study Start Date: August 2011
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422421

Contacts
Contact: Shinichiro Ueda, MD, PhD +81-98-895-1195 blessyou@med.u-ryukyu.ac.jp
Contact: Takeshi Morimoto, MD, PhD ceo@icekyoto.org

Locations
Japan
University Hospital, University of the Ryukyus Recruiting
Nishihara, Okinawa, Japan, 903-0215
Contact: Shinichiro Ueda, MD, PhD    81-98-895-1195    blessyou@med.u-ryukyu.ac.jp   
Contact: Uru Nezu, MD, PhD    81-98-895-1195    amadeus@med.u-ryukyu.ac.jp   
Principal Investigator: Shinichiro Ueda, MD, PhD         
Saga University Hospital Recruiting
Saga, Japan, 849-8501
Contact: Koichi Node, MD, PhD         
Principal Investigator: Koichi Node, MD, PhD         
Sponsors and Collaborators
Takeshi Morimoto
University of the Ryukyus
Investigators
Principal Investigator: Shinichiro Ueda, MD, PhD Professor of Clinical Pharmacology and Therapeutics, University of the Ryukyus
  More Information

No publications provided

Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01422421     History of Changes
Other Study ID Numbers: H21-rinsho shiken ippan-017
Study First Received: August 23, 2011
Last Updated: July 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
type 2 diabetes
coronary artery disease
hypertension
dyslipidemia

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on October 19, 2014