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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01422421
Other study ID # H21-rinsho shiken ippan-017
Secondary ID
Status Recruiting
Phase Phase 4
First received August 23, 2011
Last updated March 25, 2018
Start date August 2011
Est. completion date December 2029

Study information

Verified date March 2018
Source Kyoto University, Graduate School of Medicine
Contact Shinichiro Ueda, MD, PhD
Phone +81-98-895-1195
Email blessyou@med.u-ryukyu.ac.jp
Is FDA regulated No
Health authority
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 Recruiting
Enrollment 1000
Est. completion date December 2029
Est. primary completion date March 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

Study Design


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
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