UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008042 |
|---|---|
| Receipt number | 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 07:09:44 |
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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
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
maruyama_takao@kawaswaki-hospital-kobe.or.jp
Sponsor or person
Institute
Kawasaki Hospital
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
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
Value
https://center6.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 | |
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| Registered date | File name |
