UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008060 |
|---|---|
| Receipt number | R000006835 |
| Scientific Title | Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy |
| Date of disclosure of the study information | 2012/05/31 |
| Last modified on | 2020/07/28 11:14:48 |
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Basic information
Public title
Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Acronym
Rapid Estimate
Scientific Title
Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Scientific Title:Acronym
Rapid Estimate
Region
| Japan |
Condition
Condition
Ischemic heart disease, Coronary atherosclerosis
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the appropriate additional therapy for endotherial function among hyperlipidemic patients uncontrolled with statin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Improvement of endothelial function
Key secondary outcomes
small dense LDL, high sensitivity CRP, oxidized LDL(MDA-LDL), pentraxin 3, high-molecular weight adiponectin, apolipoprotein A-1/B
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of atorvastatin 20mg for 6 months
Interventions/Control_2
Administration of atorvastatin 10mg plus ezetimibe 5mg for 6 months
Interventions/Control_3
Administration of atorvastatin 10mg plus ezetimibe 10mg for 6 months
Interventions/Control_4
Administration of atorvastatin 10mg plus eicosapentaenoic acid 1800mg for 6 months
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with ischemic heart disease or coronary atherosclelosis.
2.LDL cholesterol level is from 100mg/dl to 120mg/dl with 10mg of atorvastatin.
3.No drug change during latest 3 months.
4.No history of revascularization during latest 3 months.
Key exclusion criteria
1.Patients with liver disease (ALT or AST level is over 100IU/L, total Bil level is over 2.5mg/dl).
2.Patients with renal insufficiency (serum creatinine level is over 2.0mg/dl, or creatinine clearance is under 30mL/min/1.73m2).
3.Patients with congenital heart disease.
4.Patients within 3 months from myocardial infarction and with highly advanced cardiac dysfunction.
5.Patients with endocrine disease.
6.Patients with malignancy or inflammatory disease.
7.Patinets with highly advanced respiratory disease (containing pulmonary arterial pulmonary hypertension.
8.Patients with cranial nerve disease or locomotor apparatus disease, and severely compromised daily life.
9.Patients with severe hypertension.
10.Patients administrated steroid or immune suppressor.
11.Patients with type1 DM or poorly controled type2 DM(FBS>200mg/dl, HbA1c>10.0%)
12.Patients during pregnancy or with possibility of pregnancy.
13.Patients administrated catecholamine.
14.Patients with symptomatic hypotension.
15.Patients with significant LVOT obstruction (Hypertrophic obstructive cardiomyopathy or aortic stenosis).
16.Patients recognized inadequate by primary doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoritaka |
| Middle name | |
| Last name | Otsuka |
Organization
Fukuoka wajiro hospital
Division name
Cardiology
Zip code
8110213
Address
2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
TEL
092-608-0001
yotsuka@f-wajirohp.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Koyama |
Organization
Fukuoka wajiro hospital
Division name
Cardiology
Zip code
8110213
Address
2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
TEL
092-608-0001
Homepage URL
taku-koyama@umin.ac.jp
Sponsor or person
Institute
Fukuoka wajiro hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Cerebral Cardiovascular Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka wajiro hospital
Address
2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
Tel
092-608-0001
fwh-yakuri@deluxe.ocn.ne.jp
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
池友会福岡和白病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 31 | 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
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006835
