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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003746
Receipt No. 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

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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
Email

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
Email nobori-circ@umin.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Akita University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004538

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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