UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010040
Receipt number R000011758
Scientific Title Effect on the vascular endothelium function of aggressive lipid control treatment with rosuvastatin -evaluation of a vascular endothelium function by Endo-PAT 2000-
Date of disclosure of the study information 2013/03/01
Last modified on 2014/09/17 16:41:24

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Basic information

Public title

Effect on the vascular endothelium function of aggressive lipid control treatment with rosuvastatin
-evaluation of a vascular endothelium function by Endo-PAT 2000-

Acronym

EARTH Study

Scientific Title

Effect on the vascular endothelium function of aggressive lipid control treatment with rosuvastatin
-evaluation of a vascular endothelium function by Endo-PAT 2000-

Scientific Title:Acronym

EARTH Study

Region

Japan


Condition

Condition

The patients with hyper-LDL-cholesterolemia and stable coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the impact on the vascular endothelium function by using Endo-PAT2000 via the intensive lipid control by rosuvastatin in the patients with hyper-LDL-cholesterolemia and stable coronary artery diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes of amount and rate in RH-PAT index determined by EndoPAT2000 on the vascular endothelial function after 24 weeks of rousvastatin therapy

Key secondary outcomes

Changes in serum lipid profile (LDL-C, TG, HDL-C), Changes in various markers ( MDA-LDL, hs-CRP, hs-cTnT ), Changes in the marker of renal function (cystatin C, urine albumin, eGFR)


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

rosuvastatin 2.5-20mg/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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Dyslipidemia (untreated patients: LDL-C > 100 mg/dL, treated patients: LDL-C value does not matter, but the patient treated with rosuvastatin should be excluded.)
2) Outpatient > 20 years old (at obtaining the informed consent), and gender is unquestioned.
3) The patients who we can obtain the informed consent signed by themselves.

Key exclusion criteria

1) Patients within 72 hr after the incidence of acute myocardial infarction.
2) Patients to be required the revascularization within 48 hours.
3) Familial hypercholesterolemia or
secondary hypercholesterolemia
4) Patients with the value over 400mg/dL of fasting serum triglyceride.
5) Patients with history of
hypersensitivity to statin.
6) Severe diabetes patients whose
hemoglobin A1c are > 8.5%.
7) Active hepatic disease patients with > 100 IU/L of either ALT or AST, or with > 2.5 mg/dL of total bilirubin.
8) Patients with either <30 ml/min of creatinine clearance or > 2.0 mg/dL of serum creatinine.
9) Patients receiving cyclosporine.
10) Patients during pregnancy and with pregnant possibility.
11) Patients with hypothyroidism, hereditary myopathy (such as muscular dystrophy), a family history or a history of muscle disorder resulted from drug.
12) Patients with drug abuse or alcohol addiction.
13) Patients who are judged ineligible for any other reasons by the investigator.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Hirayama

Organization

Nihon University School of Medicine

Division name

Division of Cardiology

Zip code


Address

30-1, Oyaguchi Kami-chou, Itabshi-ku, Tokyo, Japan

TEL

03-3972-8111

Email

hirayama.atsushi@nihon-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tadateru Takayama

Organization

Nihon University School of Medicine

Division name

Division of Cardiology

Zip code


Address

30-1 Oyaguchi Kamichou, Itabashiku, Tokyo, Japan

TEL

03-3972-8111

Homepage URL


Email

takayama.tadateru@nihon-u.ac.jp


Sponsor or person

Institute

Division of Cardiology, Department of Internal Medicine, Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Cardiology, Department of Internal Medicine, Nihon University School of Medicine

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

2013 Year 03 Month 01 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

2012 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 02 Month 14 Day

Last modified on

2014 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011758


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name