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
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
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
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
