UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001086
Receipt number R000000875
Scientific Title Effect of antiplatlet treatment on arterial elasticity
Date of disclosure of the study information 2008/03/20
Last modified on 2010/03/24 13:50:39

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Basic information

Public title

Effect of antiplatlet treatment on arterial elasticity

Acronym

TRIS(Trial of HMG-CoA Reductase Inhibitor for atheroSclerosis)

Scientific Title

Effect of antiplatlet treatment on arterial elasticity

Scientific Title:Acronym

TRIS(Trial of HMG-CoA Reductase Inhibitor for atheroSclerosis)

Region

Japan


Condition

Condition

type2 diabetes with dyslipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of HMG-CoA reductase inhibitor on arterial elasticity of diabetic subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

change of carotid arterial elasticity

Key secondary outcomes

changes of serum markers of atheroscrerosis,pulse wave velocity and carotid intima-media thickness


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pravastatin 10mg daily

Interventions/Control_2

Atrovastatin 10mg 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

30 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

type2 diabetes with dyslipidemia(LDL cholesterol over 120mg/dl)

Key exclusion criteria

severe liver dysfunction
severe renal dysfunction
familial hypercholesterolemia
severe retinopathy
severe vascular disease with urgent treatment
HbA1c over 9%
blood pressure over 180/100 mmHg

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitomo Oka

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Molecular Metabolism and Diabetes

Zip code


Address

Seiryoumachi1-1,Aobaku,Sendai

TEL

022-717-7611

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasushi Ishigaki

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Molecular Metabolism and Diabetes

Zip code


Address

Seiryoumachi1-1,Aobaku,Sendai

TEL

022-717-7611

Homepage URL


Email

yishigaki@mail.tains.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Medicine, Division of Molecular Metabolism and Diabetes

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Graduate School of Medicine, Division of Molecular Metabolism and Diabetes

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

2008 Year 03 Month 20 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

2007 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry

2010 Year 01 Month 01 Day

Date trial data considered complete

2010 Year 02 Month 01 Day

Date analysis concluded

2010 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 03 Month 18 Day

Last modified on

2010 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000875


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name