UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010323 |
|---|---|
| Receipt number | 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 13:25:11 |
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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
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
jun-m@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001616
