UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005489 |
|---|---|
| Receipt number | R000005763 |
| Scientific Title | Effect of Pitavastatin on the coronary endothelial dysfunction after PCI with DES (Drug-eluting stent) |
| Date of disclosure of the study information | 2011/04/22 |
| Last modified on | 2020/03/11 17:07:29 |
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Basic information
Public title
Effect of Pitavastatin on the coronary endothelial dysfunction after PCI with DES (Drug-eluting stent)
Acronym
Effect of Pitavastatin on the coronary endothelial dysfunction after PCI with DES (Drug-eluting stent)
Scientific Title
Effect of Pitavastatin on the coronary endothelial dysfunction after PCI with DES (Drug-eluting stent)
Scientific Title:Acronym
Effect of Pitavastatin on the coronary endothelial dysfunction after PCI with DES (Drug-eluting stent)
Region
| Japan |
Condition
Condition
Patients with coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevention from coronary endothelial dysfunction for CAD after PCI by pitavastatin 1mg/day or pitavastatin 4mg/day
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A rate of change of Coronary blood flow by acetylcholine provocation
Key secondary outcomes
1.The changes in vessel diameter on target vessel and non-target vessel by acetylcholine provocation
2.The changes in TC, LDL-C, TG, HDL-C, non-HDL-C, LDL-C/HDL-C, RLP-C and MDA-LDL
3.The Correlation between change in lipid profiles and change in Coronary blood flow by acetylcholine provocation
4.The Correlation between change in lipid profiles and change in coronary blood vessel diameter of target vessel and non-target vessel by acetylcholine provocation
5.Changes in inflammation marker (hs-CRP)
6.The Correlation between change in inflammation marker and change in Coronary blood flow by acetylcholine provocation
7.The Correlation between change in inflammation marker and change in coronary blood vessel diameter of target vessel and non-target vessel by acetylcholine provocation
8.The incidence rate of adverse event
9.The changes in laboratory values
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin 4 mg daily
Interventions/Control_2
Pitavastatin 1 mg 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with coronary artery disease planed PCI only LCA
2.Hypercholesterolemia patients Meeting one of following criteria
a)TC is 220 mg/dL or over
b)LDL-C is 140 mg/dL or over
c)LDL-C is 100 mg/dL or over or TC is 180 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
3.Age (20<= <80 year-old)
4.Patients given written informed consent
Key exclusion criteria
1.A PCI target lesion with graft disease or in-stent restenosis
2.Patients who have skip lesion without PCI target lesion, and planed PCI within this examination. But it does not limit the PCI by a disease of the right coronary artery
3.Stent which is BMS to use for PCI
4.Malignant tumor in active phase
5.Patients who meet contraindication of LIVALO tablet below
a)Patients who have hypersensitivity to LIVALO tablet
b)Patients who have severe liver dysfunction or biliary atresia
c)Patients who are being treated with cyclosporine
d)Pregnant women, women suspected of being pregnant, or lactating women
6.Patients with hypersensitive to contrast media
7.Patients with liver dysfunction [ALT(GPT) 100 IU/L <=]
8.Patients undergoing dialysis
9.Patients with familial hypercholesterolemia
10.Patients who are ineligible in the opinion of the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuki Kihara |
Organization
Hiroshima University hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kurisu |
Organization
Hiroshima University hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University 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
None
Name of secondary funder(s)
None
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
| 2011 | Year | 04 | Month | 22 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 22 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005763
