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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010323
Receipt No. R000001616
Scientific Title A study to evaluate the effect of ezetimibe and rosuvastatin on intravascular ultrasound-derived coronary atheroma and lipid lowering effect.
Date of disclosure of the study information 2013/03/27
Last modified on 2017/07/25

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Basic information
Public title A study to evaluate the effect of ezetimibe and rosuvastatin on intravascular ultrasound-derived coronary atheroma and lipid lowering effect.
Acronym Mie study of Ezetimibe and Rosvastatin for attenuation of coronary artery atherosclerosis by using Intravascular ultrasound (MERIT study)
Scientific Title A study to evaluate the effect of ezetimibe and rosuvastatin on intravascular ultrasound-derived coronary atheroma and lipid lowering effect.
Scientific Title:Acronym 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
1st name
Middle name
Last name Mashio Nakamura
Organization Mie University Graduate School of Medicine
Division name Department of Cardiovascular Research
Zip code
Address 2-174 Edibashi, Tsu, Mie
TEL 059-231-5015
Email mashio@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Masuda
Organization Mie University Graduate School of Medicine
Division name Department of Cardiology and Nephrology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/ihj/56/3/56_14-311/_pdf
Number of participants that the trial has enrolled
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.
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 Main results already published
Date of protocol fixation
2008 Year 08 Month 01 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001616

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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