UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Hiroshima University hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005763