We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified March 2017 by Takeshi Morimoto, Kyoto University, Graduate School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422421
First Posted: August 24, 2011
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of the Ryukyus
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
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 Takeshi Morimoto, Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • composite endpoint [ Time Frame: 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 [ Time Frame: 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:
  • all-cause mortality [ Time Frame: 3 years ]
    death due to any cause

  • myocardial infarction [ Time Frame: 3 years ]
    non fatal myocardial infarction

  • stroke [ Time Frame: 3 years ]
    non fatal stroke excluding transient ischemic attack

  • Cardiovascular death [ Time Frame: 3 years ]
    Cardiovascular death

  • end stage renal disease [ Time Frame: 3 years ]
    end stage renal disease needs kidney transplantation or hemodialysis

  • peripheral artery disease [ Time Frame: 3 years ]
    peripheral artery disease

  • new onset or deterioration of heart failure [ Time Frame: 3 years ]
    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: March 2021 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 23, 2011
First Posted: August 24, 2011
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Takeshi Morimoto, 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