UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005159 |
|---|---|
| Receipt number | R000006126 |
| Scientific Title | Effects of low versus high dose of pitavastatin on indices of atherosclerosis in patients with coronary artery disease |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2014/09/02 04:02:32 |
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Basic information
Public title
Effects of low versus high dose of pitavastatin on indices of atherosclerosis in patients with coronary artery disease
Acronym
Effects of low versus high dose of Pitavastatin on Indices of atheroSclerosis in patients with cOronary artery DiseasE (EPISODE)
Scientific Title
Effects of low versus high dose of pitavastatin on indices of atherosclerosis in patients with coronary artery disease
Scientific Title:Acronym
Effects of low versus high dose of Pitavastatin on Indices of atheroSclerosis in patients with cOronary artery DiseasE (EPISODE)
Region
| Japan |
Condition
Condition
Coronary artery disease with dyslipidemia
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although atherosclerosis is characterized by an increase in arterial wall thickness, formation of atheroma, and arterial stiffening, most studies on vascular effects of statins have not been focused on arterial stiffness. Arterial stiffness can be evaluated by the measurement of pulse wave velocity (PWV), augmentation index (AI), and central aortic pressure that reflects an increase in AI caused by arterial stiffening. Thus, the present study was designed to investigate effects of pitavastatin on PWV, AI, and central aortic pressure in patients with coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in brachial-ankle PWV (baPWV), AI, and central aortic pressure
Key secondary outcomes
Changes in lipid profile, malondialdehyde-modified (MDA)-LDL, apolipoprotein B, apolipoprotein A-I
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EISODE is a 12-months, prospective, randomized, open, blinded-endpoint (PROBE) study. Patients with coronary artery disease and increased LDL-cholesterol are enrolled and anti-dyslipidemic medications are either started on or switched to pitavastatin (1 mg/day) monotherapy. After a 4-week run-in period, baseline evaluations are performed. Then, patients are assigned to receive pitavastatin (4 mg/day) for 12 months. In cases that LDL-cholesterol levels do not reach the target level (<100mg/dL), antidyslipidemic drugs other than statins are prescribed to achieve the target level.
Interventions/Control_2
After a 4-week run-in period, baseline evaluations are performed. Then, patients are assigned to receive pitavastatin (1 mg/day) for another 12 months. In cases that LDL-cholesterol levels do not reach the target level (<100mg/dL), antidyslipidemic drugs other than statins are prescribed to achieve the target level.
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
Patients are eligible for inclusion in the study if (1) they are >=20 years of age; (2) have coronary artery disease (previous acute coronary syndrome or revascularization >3 months before informed consent, or stable angina pectoris with significant angiographical coronary stenosis (>=75%); and (3) have elevated LDL-cholesterol (>=100 mg/dL) or receive antidyslipidemic treatment.
Key exclusion criteria
Severe heart failure (ejection fraction <30% or NYHA III or IV), malignant neoplasm, active inflammatory disease, familial hyperlipidemia, chronic hemodialysis, pregnancy, contra-indication to pitavastatin
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takase |
Organization
Enshu Hospital
Division name
Department of Internal Medicine
Zip code
Address
1-1-1 Chuo, Naka-ku, Hamamatsu, Japan
TEL
053-453-1111
h-takase@ken.ja-shizuoka.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Dohi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Cardio-Renal Medicine and Hypertension
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8221
Homepage URL
ydohi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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)
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
| 2011 | 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
| 2010 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 01 | Day |
Last modified on
| 2014 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006126
