UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008303
Receipt No. R000009781
Official scientific title of the study Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.
Date of disclosure of the study information 2012/06/30
Last modified on 2012/06/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.
Title of the study (Brief title) TART study
Region
Japan

Condition
Condition Hypercholesterolemia with carotid artery plaque
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of pitavastatin on the carotid plaques in patients with hypercholesterolemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Qualitative and quantitative change of carotid artery plaque by carotid artery echo and MRI evaluation.
Key secondary outcomes 1)Change of serum lipids(TC,LDL-C,TG,HDL-C).
2)Incidence rate of event.
3)Change of hs-CRP and osteopontin.
4)Evaluation of carotid artery plaque by microbubble contrast material.
5)Evaluation of carotid artery plaque by contrast-enhanced CT.
6) Relationship of change of carotid artery plaque and serum lipids, blood marker.
7)Change of intracranial stenosis.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin will be administered for 6 months at a dosage of 1~4 mg/day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)The patient who observed the plaque in the carotid artery by MRI(Not less than 50% of the degree of stenosis).
2)The patient who is going not to perform CAS and CEA etc. but to perform
Follow up.
3)At the time of entry, pitavastatin is not taken.
4)Patients with hypercholesterolemia.
5)Patients aged 20 years or older at the time of giving consent.
6)Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial.
Key exclusion criteria 1)At the time of entry, pitavastatin is taken.
2)The patient who had enforced CAS in the past to the carotid artery plaque lesion which evaluates.
3)Patients who have hypersensitivity to LIVALO tablet.
4)Patients who are being treated with cyclosporine.
5)Patients who have liver dysfunction
The following patients considered that biliary obstruction or liver metabolism ability is falling(acute hepatitis, Acute aggravation of chronic hepatitis, hepatic cirrhosis, hepatoma, jaundice)
6)Pregnant women, women suspected of being pregnant, or lactating women
7)Patients who have renal dysfunction, or undergoing dialysis.
8)Patients who are ineligible in the opinion of the investigator.
Target sample size 50

Research contact person
Name of lead principal investigator Yoshiaki Kumon
Organization Ehime University
Division name Neurosurgery
Address Shitsukawa, Toon-shi, Ehime
TEL 089-964-5338
Email

Public contact
Name of contact person Yoshiaki Kumon
Organization Ehime University
Division name Neurosurgery
Address Shitsukawa, Toon-shi, Ehime
TEL 089-964-5338
Homepage URL
Email ykumon@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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
2012 Year 06 Month 30 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 05 Month 28 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2012 Year 06 Month 29 Day
Last modified on
2012 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009781


Contact us.