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NCT Number: NCT01422421

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

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.

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Key information

Conditions

Type 2 Diabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, University of the Ryukyus, Nishihara, Okinawa, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intensive control

Other

use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl

Standard Control

Other

use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl

Primary outcomes

  1. 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

  2. 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 outcomes

  1. all-cause mortality

    Time frame: 3 years

    death due to any cause

  2. myocardial infarction

    Time frame: 3 years

    non fatal myocardial infarction

  3. stroke

    Time frame: 3 years

    non fatal stroke excluding transient ischemic attack

  4. Cardiovascular death

    Time frame: 3 years

    Cardiovascular death

  5. end stage renal disease

    Time frame: 3 years

    end stage renal disease needs kidney transplantation or hemodialysis

  6. peripheral artery disease

    Time frame: 3 years

    peripheral artery disease

  7. new onset or deterioration of heart failure

    Time frame: 3 years

    new onset or deterioration of heart failure

Sponsors and collaborators

Lead sponsor

Takeshi Morimoto

Other

Collaborators

  • University of the Ryukyus

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2022
Study completion
2023
First posted
Aug 24, 2011
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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