UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001404 |
|---|---|
| Receipt number | R000001709 |
| Scientific Title | TOHO lipid intervention trial using pitavastatin(TOHO-LIP) |
| Date of disclosure of the study information | 2008/09/30 |
| Last modified on | 2008/09/30 22:20:03 |
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Basic information
Public title
TOHO lipid intervention trial using pitavastatin(TOHO-LIP)
Acronym
TOHO-LIP
Scientific Title
TOHO lipid intervention trial using pitavastatin(TOHO-LIP)
Scientific Title:Acronym
TOHO-LIP
Region
| Japan |
Condition
Condition
hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology | Vascular surgery | Neurosurgery |
| Cardiovascular surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a strategy for treatment of macrovascular disease using pitavastatin and atorvastatin in high risk cardiac patients with hypercholesterolemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary end-point (composite end-point):
1. Cardiac disease
a. Non-fatal myocardial infraction
b. Angina
c. Congestive heart failure
2. Recent coronary revascularization
3. Non-fatal cerebrovascular event
a. Cerebral apoplexy
b. Cerebral infarction
c. Subarachnoid hemorrhage
d. Transient ischemic attack
4. Peripheral artery disease
a. Arteriosclerosis obliterans
b. Aortic aneurysm
5. Lower limb amputation
6. Lower limb bypass surgery or revascularization procedure
7. Fatal acute myocardial infarction or fatal cerebrovascular event
8. Sudden death
Key secondary outcomes
1. Time to development of composite primary endpoint
2. Incidence of individual primary endpoints
3. Time to development of incidence of individual primary endpoints
4. Incidence of diabetic nephropathy
5. Incidence of atrial fibrillation
6. Non-HDL-C; LDL-C; HDL-C; Triglyceride; Serum creatinine; Fasting plasma glucose; HbA1c or glycosylated albumin; 0.5% increase of HbA1c; Preheparin LPL mass; Urinary albumin; Urinary 8-hydroxydeoxyguanosine(OhdG); 8-iso-prostaglandin F2 alpha(PGF2alpha); Small dense LDL
7. Non-HDL-C goal of the NCEP Adult Treatment Panel III
8. LDL-C goal of Japan Atherosclerosis Society(JAS) Guidelines 2002
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin 2mg will be administered after a meal in the evening.
Duration of treatment: 5 years
Interventions/Control_2
Atorvastatin 10mg will be administered after a meal in the evening.
Duration of treatment: 5 years
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Hypercholesterolemia(TC>=220mg/dL, LDL-C>=140mg/dL)
2. Patient who has one or more of arteriosclerosis disease risk factors
a. Type 2 diabetes(HbA1c>=6.0%, GA>=18.0%)
b. Ischemic heart disease patients who have 50% or more stenosis in a coronary artery
c. Acute MI or unstable angina
d. PCI or CABG
e. Cerebral infarction
f. Arteriosclerosis obliterans
4. Age 35 or more
5. Men and women
6. Written consent for participation in the study by their own volition after being provided sufficient explanation for participation into this clinical trial
Key exclusion criteria
1. Heart failure NYHA III or greater
2. Severe nephropathy
3. Scheduled for PCI, CABG and leg procedure for peripheral vascular disease
4. Malignancy or high risk for malignancy
5. Uncontrolled diabetes
6. Receiving probucol
7. Familial hypercholesterolemia
8. Contraindication or relative contraindication to statin Rx
9. Individuals who are ineligible in the opinion of the investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohji Shirai |
Organization
Toho University Sakura Medical Center
Division name
Center of Diabestes, Endocrinology & Metabolism
Zip code
Address
564-1 Shimoshizu Sakura, Chiba 285-8741, Japan
TEL
043-462-8811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoh Miyashita |
Organization
Toho University Sakura Medical Center
Division name
Center of Diabestes, Endocrinology & Metabolism
Zip code
Address
564-1 Shimoshizu Sakura, Chiba 285-8741, Japan
TEL
043-462-8811
Homepage URL
Sponsor or person
Institute
Toho University Sakura Medical Center
Center of Diabestes, Endocrinology & Metabolism
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Toho University Oomori Medical Center
Toho University Ohashi Medical Center
Toho University Faculty of Pharmaceutical Sciences
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
| 2008 | Year | 09 | Month | 30 | 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
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 30 | Day |
Last modified on
| 2008 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001709
