UMIN-CTR Clinical Trial

Basic information
Public title	Prospective, randomized, open-label, clinical trial comparing the effects of statin monotherapy and statin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Acronym	Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-ezetimibe combination therapy
Scientific Title	Prospective, randomized, open-label, clinical trial comparing the effects of statin monotherapy and statin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Scientific Title:Acronym	Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-ezetimibe combination therapy
Region	Japan

Condition
Condition	Coronary artery diseases
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of statin monotherapy (high dose) and statin (standard dose)-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization Flow-mediated vasodilation in forearm, 6 months after randomization Heparin-releasable EC-SOD levels, 6 months after randomization
Key secondary outcomes	Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of statins alone (high dose)
Interventions/Control_2	Administration of statins (standard dose)-ezetimibe as a combination
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with coronary artery diseases under administration of standard doses of statins, whose LDL-C are greater than 100 mg/dl 2) Patients who have aortic atherosclerotic plaques detected by MRI 3) Outpatients 4) Subjects who gave written informed consent
Key exclusion criteria	1) Allergy against statins and ezetimibe 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>10.0 %) 4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 5) Either level of aspartate aminotransferase or alanine aminotransferase exceeds three-fold of the normal limits. 6) Chronic renal failure (serum creatinine>2.0 mg/dl) 7) Malignancies or other diseases with poor prognosis 8) Pregnant 9) Subjects whose doctor in charge do not agree to join the trial
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Katsunori Ikewaki
Organization	National Defense Medical College
Division name	Department of Internal Medicine I
Zip code
Address	3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL	04-2995-1597
Email	katsunorike@ndmc.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Makoto Ayaori
Organization	National Defense Medical College
Division name	Department of Internal Medicine I
Zip code
Address	3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL	04-2995-1597
Homepage URL
Email	ayaori@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 01 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 15 Day
Date of IRB	2007 Year 07 Month 31 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 01 Month 02 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003352