Intensive Blood Pressure and LDL Lowering in Diabetic Patients With Coronary Artery Disease
This study is currently recruiting participants.
Verified July 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Takeshi Morimoto
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
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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:
MedlinePlus related topics:
Cholesterol
Coronary Artery Disease
Diabetes
Diabetes Type 2
High Blood Pressure
U.S. FDA Resources
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
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:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Hypertension Dyslipidemias Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on May 19, 2013