UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of ezetimibe and rosuvastatin on intravascular ultrasound-derived coronary atheroma and lipid lowering effect.
Title of the study (Brief title)	Mie study of Ezetimibe and Rosvastatin for attenuation of coronary artery atherosclerosis by using Intravascular ultrasound (MERIT study)
Region	Japan

Condition
Condition	dyslipidemia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare of the coronary artery plaque volume between statin only and statin eith ezetimibe by intravascular-ultrasound.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in coronary atheroma by serial volumetoric intravascular-ultrasound analysis
Key secondary outcomes	body mass index, serum LDL-C, HDL-C, TG, non-HDL, small dense LDL, hs-CRP, HOMA-IR, oxidized LDL and hs-CRP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is 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	statin only arm
Interventions/Control_2	statin with ezetimibe arm
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	Not applicable
Gender	Male and Female
Key inclusion criteria	men and women abobe 20 years of age and LDL-chol moreover 100mg/dl with a clinical indication for coronary catheterization therapy and provided written informed consent
Key exclusion criteria	1, privious allergy for ezetimibe or any of statins 2, contraindication for rosuvastatin and already recieved rosuvastatin 3, secondary dyslipidemia 4, history of acute coronary syndrome within 3months before study entry 5, congestive heart failure (NYHA 3 or 4) 6, low left ventricular contractility 7, inducation for coronary artery bypass graft 8, poor control HTN patient (systolic BP over 220mmHg, diastolic BP over 110mmHg) 9, poor control diabetic patient (HbA1c over 9.5%) 10, hemodialysis patient 11, severe renal dysfunction (30 over CCr or serum Cre over 2.0) 12, serum CK over 300 13, severe liver dysfunction
Target sample size	50

Research contact person
Name of lead principal investigator	Mashio Nakamura
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiovascular Research
Address	2-174 Edibashi, Tsu, Mie
TEL	059-231-5015
Email	mashio@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Jun Masuda
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	2-174 Edibashi, Tsu, Mie
TEL	059-231-5015
Homepage URL
Email	jun-m@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Clinical Research Support Center, Mie University Hospital
Name of secondary funｄer(s)

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	三重大学医学部附属病院（三重県） Mie University Hospital (Mie)

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 08 Month 01 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2013 Year 04 Month 05 Day
Date of closure to data entry	2013 Year 04 Month 11 Day
Date trial data considered complete	2013 Year 05 Month 27 Day
Date analysis concluded	2013 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/ihj/56/3/56_14-311/_pdf
Results	Intensive lipid-lowering therapy with ezetimibe provide greater reduction in the percent change in plaque volume (PV), the primary endpoint, than the statin monotherapy group (-13.2% versus -3.1%, respectively, P = 0.050).Moreover, percent change in PV showed positive correlations with percent change of LDL-C (r = 0.384, P = 0.015). Intensive lipid-lowering therapy with ezetimibe added to usual-dose statin may provide significant incremental reduction in coronary plaques compared with usual-dose statin monotherapy.
Other related information

Management information
Registered date	2013 Year 03 Month 27 Day
Last modified on	2017 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001616