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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005774
Receipt No. R000006788
Scientific Title Justification for Atherosclerosis Regression Treatment [JART Extension Study]
Date of disclosure of the study information 2011/06/14
Last modified on 2013/08/30

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Basic information
Public title Justification for Atherosclerosis Regression Treatment
[JART Extension Study]
Acronym JART
[JART Extension Study]
Scientific Title Justification for Atherosclerosis Regression Treatment
[JART Extension Study]
Scientific Title:Acronym JART
[JART Extension Study]
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of intensive Rosuvastatin therapy for lipids on regression of carotid artery intima-media thickness (IMT) compared to conventional Pravastatin therapy for patients with hypercholesterolemia .
Furthermore, to investigate long-term safety and efficacy in the intensive therapy group.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes % change from baseline in mean-IMT at the end of 24 months.
Key secondary outcomes 1) Time to % change in mean-IMT.
2) Time to % change in max-IMT of the distal wall of the common carotid artery (IMT-Cmax-distal wall).
3) Time to % change in IMT-Cmax of common carotid artery, IMT-Bmax of carotid sinus, and IMT-Imax of internal carotid artery.
4) Percentage of cases in which mean-IMT decreased at the end of 12 months and 24 months.
5) Time to % change in LDL-C / HDL-C ratio.
6) Percentage of cases in which LDL-C / HDL-C ratio <= 1.5 at the end of 12 months and 24 months.
7) Percentage of cases in which LDL-C / HDL-C ratio <= 2.0 at the end of 12 months and 24 months.
8) Correlation between LDL-C / HDL-C ratio and max-IMT.
9) Correlation between LDL-C / HDL-C ratio and mean-IMT.
10) Time to % change of serum lipids (LDL-C, HDL-C, and TG), HbA1c, systolic blood pressure, and diastolic blood pressure.
11) JASGL2007 achievement ratio according to the management target level of LDL-C .
12) Cumulative incidence and content of cardiovascular and cerebral vascular events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 5 mg Rosuvastatin will be orally administered once daily for two years.
Target LDL-C levels are 80 mg/dL for primary prevention, and 70 mg/dL for secondary prevention. If these levels are not achieved, doses are gradually increased (e.g. Rosuvastatin (10 mg/day), Rosuvastatin (10 mg/day) + another hypolipidemic drug).
Interventions/Control_2 10 mg Pravastatin will be orally administered once daily for two years. Target LDL-C levels are in compliance with JASGL2007. If these levels are not achieved, doses are gradually increased (e.g. Pravastatin (20 mg/day), Pravastatin (20 mg/day) + another hypolipidemic drug).
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Hypercholesterolemia (LDL-C >= 140 mg/dL)
(2) Patients with a max-IMT level of 1.1 mm or greater
(3) Hospital stay or hospital visit: no object.
(4) Patients who are able to submit written consent agreement by themselves.
Key exclusion criteria (1) Patients that require lipid-lowering therapy other than the study drug or specified lipid-lowering drugs (anion-exchange resin, inhibitor of probucol, and ethyl icosapentate (EPA))
(2) Patients who have taken statins within one month before the start of the clinical trial.
(3) Patients suspected of having serious carotid artery stenosis (greater than 80%) or having serious calcification.
(4) Patients with familial hypercholesterolemia or secondary hypercholesterolemia.
(5) Patients with fasting serum TG >= 400 mg/dL.
(6) Patients with a history of sensitivity to statins.
(7) Patients with uncontrolled hypertension.
(8) Patients with Type I diabetes or uncontrolled Type II diabetes.
(9) Patients who have experienced myocardial infarction or a cerebral stroke within 3 months or Patients with serious heart failure (NYHA class III to IV).
(10) Patients with active hepatic disease.
(11) Patients with renal disorder (Cr >= 2.0 mg/dL or Ccr < 30 mL/min/1.73m2).
(12) Patients with CK > 500 IU/L.
(13) Patients currently being treated with cyclosporine.
(14) Patients that are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial.
(15) Patients with or suspected of having a malignant tumor, or patients with a history of malignant tumor except for the patients in whom recurrences have not been confirmed by routine observation after treatment.
(16) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder.
(17) Patients with drug abuse or alcoholic.
(18) Patients who are ineligible in the opinion of the investigator.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuji Nohara
Organization Hirakata Kohsai Hospital
Division name President, Heart Center
Zip code
Address 1-2-1 Fujisakahigashimachi, Hirakata, Osaka, Japan
TEL 072-858-8233
Email r-nohara@kkr-hirakoh.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshifumi Kakutani
Organization JART Study Support Center
Division name Mebix Inc.
Zip code
Address Akasaka Intercity, 1-11-44, Akasaka Minato-ku, Tokyo, 107-0052, Japan
TEL 03-6229-8936
Homepage URL
Email j-art@mebix.co.jp

Sponsor
Institute Japan Atherosclerosis Regressive Treatment Study Group
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 06 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Nohara R et al. : Circ J. 2012;76(1): 221-229

Nohara R et al. : Circ J 2013; 77(6): 1526 -1533
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
2008 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 01 Month 31 Day
Date trial data considered complete
2012 Year 02 Month 07 Day
Date analysis concluded
2012 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 14 Day
Last modified on
2013 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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