UMIN-CTR Clinical Trial

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

Patients with coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Hiroshima University hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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