UMIN-CTR Clinical Trial

Basic information
Public title	Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Acronym	Rapid Estimate
Scientific Title	Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Scientific Title:Acronym	Rapid Estimate
Region	Japan

Condition
Condition	Ischemic heart disease, Coronary atherosclerosis
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the appropriate additional therapy for endotherial function among hyperlipidemic patients uncontrolled with statin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Improvement of endothelial function
Key secondary outcomes	small dense LDL, high sensitivity CRP, oxidized LDL(MDA-LDL), pentraxin 3, high-molecular weight adiponectin, apolipoprotein A-1/B

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of atorvastatin 20mg for 6 months
Interventions/Control_2	Administration of atorvastatin 10mg plus ezetimibe 5mg for 6 months
Interventions/Control_3	Administration of atorvastatin 10mg plus ezetimibe 10mg for 6 months
Interventions/Control_4	Administration of atorvastatin 10mg plus eicosapentaenoic acid 1800mg for 6 months
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients with ischemic heart disease or coronary atherosclelosis. 2.LDL cholesterol level is from 100mg/dl to 120mg/dl with 10mg of atorvastatin. 3.No drug change during latest 3 months. 4.No history of revascularization during latest 3 months.
Key exclusion criteria	1.Patients with liver disease (ALT or AST level is over 100IU/L, total Bil level is over 2.5mg/dl). 2.Patients with renal insufficiency (serum creatinine level is over 2.0mg/dl, or creatinine clearance is under 30mL/min/1.73m2). 3.Patients with congenital heart disease. 4.Patients within 3 months from myocardial infarction and with highly advanced cardiac dysfunction. 5.Patients with endocrine disease. 6.Patients with malignancy or inflammatory disease. 7.Patinets with highly advanced respiratory disease (containing pulmonary arterial pulmonary hypertension. 8.Patients with cranial nerve disease or locomotor apparatus disease, and severely compromised daily life. 9.Patients with severe hypertension. 10.Patients administrated steroid or immune suppressor. 11.Patients with type1 DM or poorly controled type2 DM(FBS>200mg/dl, HbA1c>10.0%) 12.Patients during pregnancy or with possibility of pregnancy. 13.Patients administrated catecholamine. 14.Patients with symptomatic hypotension. 15.Patients with significant LVOT obstruction (Hypertrophic obstructive cardiomyopathy or aortic stenosis). 16.Patients recognized inadequate by primary doctor.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yoritaka Middle name Last name Otsuka
Organization	Fukuoka wajiro hospital
Division name	Cardiology
Zip code	8110213
Address	2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
TEL	092-608-0001
Email	yotsuka@f-wajirohp.jp

Public contact
Name of contact person	1st name Taku Middle name Last name Koyama
Organization	Fukuoka wajiro hospital
Division name	Cardiology
Zip code	8110213
Address	2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
TEL	092-608-0001
Homepage URL
Email	taku-koyama@umin.ac.jp

Sponsor
Institute	Fukuoka wajiro hospital
Institute
Department

Funding Source
Organization	Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Cerebral Cardiovascular Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka wajiro hospital
Address	2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
Tel	092-608-0001
Email	fwh-yakuri@deluxe.ocn.ne.jp

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	池友会福岡和白病院（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 31 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	2011 Year 07 Month 01 Day
Date of IRB	2012 Year 05 Month 31 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2019 Year 12 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 05 Month 30 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006835