UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003746 |
|---|---|
| Receipt number | R000004538 |
| Scientific Title | Pleiotropic effects of rosuvastatin in patients with coronary artery disease. A randomized, parallel, open-label study, rosuvastatin 10mg vs ezetimibe 10mg/rosuvastatin 2.5mg. |
| Date of disclosure of the study information | 2010/06/13 |
| Last modified on | 2013/10/06 16:52:39 |
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Basic information
Public title
Pleiotropic effects of rosuvastatin in patients with coronary artery disease.
A randomized, parallel, open-label study, rosuvastatin 10mg vs ezetimibe 10mg/rosuvastatin 2.5mg.
Acronym
Pleiotropic effects of rosuvastatin in patients with coronary artery disease.
Scientific Title
Pleiotropic effects of rosuvastatin in patients with coronary artery disease.
A randomized, parallel, open-label study, rosuvastatin 10mg vs ezetimibe 10mg/rosuvastatin 2.5mg.
Scientific Title:Acronym
Pleiotropic effects of rosuvastatin in patients with coronary artery disease.
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of ezetimibe 10mg/rosuvastatin 2.5mg and
rosuvastatin 10mg in achieving hsCRP reduction in patients with
coronary artery disease who failed to obtain sufficient efficacy by rosuvastatin 2.5mg.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in hsCRP after 12 weeks
Key secondary outcomes
LDL, HDL, TC, LDL/HDL, non-HDLC, MDA-LDL, IL-6, TNF-alpha, d-ROMs Test, BAP Test, PTX3
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rosuvastatin 10mg
Interventions/Control_2
rosuvastatin 2.5mg / ezetimibe 10mg
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
Patients with old myocardial infarction or post PCI
1) LDL>=70mg/dL
2) high-sensitive CRP>1mg/L
3) 20years-old<=
4) both inpatient and outpatient
5) treated with rosuvastatin 2.5mg over 8 weeks prior to the study.
Key exclusion criteria
1) acute myocardial infarction within 1 month
2) chronic and acute inflammation disease(hsCRP>10mg/L)
3) 37.0 degrees Celsius <=
4) allergy against rosuvastatin
5) allergy against ezetimibe
6) acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice
7) chronic renal failure(Cr>=2.0mg/dL or Ccr<30mL/min/1.73m2)
8) patients treated with cyclosporine
9) pregnant
10) subjects whose doctor in charge do not agree to join the trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ito |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Hondo, Akita, Japan, 010-8543
TEL
018-884-6110
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Nobori |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
nobori-circ@umin.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23374898
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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 13 | Day |
Last modified on
| 2013 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004538
