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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000008042
Receipt No. R000009472
Scientific Title Prospective analysis of ComparIson of pReventive effect on CardiovascuLar Events with different statin therapy (P-CIRCLE)
Date of disclosure of the study information 2012/05/28
Last modified on 2015/06/01

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Basic information
Public title Prospective analysis of ComparIson of pReventive effect on CardiovascuLar Events with different statin therapy
(P-CIRCLE)
Acronym Prospective analysis of ComparIson of pReventive effect on CardiovascuLar Events with different statin therapy
(P-CIRCLE)
Scientific Title Prospective analysis of ComparIson of pReventive effect on CardiovascuLar Events with different statin therapy
(P-CIRCLE)
Scientific Title:Acronym Prospective analysis of ComparIson of pReventive effect on CardiovascuLar Events with different statin therapy
(P-CIRCLE)
Region
Japan

Condition
Condition Patients with coronary artery disease who underwent PCI
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the preventive effect on cardiovascular events between atorvastatin and pitavastatin.
The patients with baseline HDL-C<45mg/dL are defined as prespecified subgroup.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Composite cardiovascular events
Occurrence of one of following events
1.Cardiovascular death
2.Non-fatal Myocardial Infarction (MI)
3.Non-fatal Cerebral Infarction (CI)
4.Repeated revascularization including bypass surgery, target lesion revascularization and repeated PCI for de novo lesion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin 2~4mg daily
Interventions/Control_2 Atorvastatin 10~20mg daily
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with hypercholesterolemia
who satisfied each criteria below
-LDL-C level is equal or greater than 100 mg/dL
-requiring cholesterol lowering drugs judged by attending physicians
2.Patients given written informed consent
Key exclusion criteria 1.Patients who met contraindication of LIVALO tablet below
- Patients who have hypersensitivity to LIVALO tablet
-Patients who have severe liver dysfunction or biliary atresia.
-Co-administration with cyclosporine
-Women who are pregnant or may become pregnant or nursing mothers
2.Patients who meet contraindication of LIPITOL tablet below
- Patients who have hypersensitivity to LIPITOL tablet
-Patients with the following diseases considered to be associated with defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus
-Women who are pregnant or may become pregnant or nursing mothers
3.Patients with hepatic disorders (ALT or AST level is equal or greater than 100IU/L)
4.Patients who are ineligible in the opinion of the investigator

Target sample size 660

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Maruyama
Organization Kawasaki Hospital
Division name Department of Cardiology
Zip code
Address 3-3-1 Higashiyama-cho, Hyogo-ku, Kobe
TEL 078-511-3131
Email maruyama_takao@kawasaki-hospital-kobe.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Maruyama
Organization Kawasaki Hospital
Division name Department of Cardiology
Zip code
Address 3-3-1 Higashiyama-cho, Hyogo-ku, Kobe
TEL 078-511-3131
Homepage URL
Email maruyama_takao@kawaswaki-hospital-kobe.or.jp

Sponsor
Institute Kawasaki Hospital
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 医療法人 川崎病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Preinitiation
Date of protocol fixation
2012 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2012 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
2012 Year 05 Month 28 Day
Last modified on
2015 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009472

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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