UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008627 |
|---|---|
| Receipt number | R000010026 |
| Scientific Title | Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease. (Shield-CAD) |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2012/08/06 08:30:35 |
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Basic information
Public title
Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease.
(Shield-CAD)
Acronym
Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease.
(Shield-CAD)
Scientific Title
Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease.
(Shield-CAD)
Scientific Title:Acronym
Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease.
(Shield-CAD)
Region
| Japan |
Condition
Condition
Patients with stable coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the HbA1c levels in patients of coronary artery disease with hypercholesterolemia, treated with some strong statin, when one statin switches to high-dose of pitavastatin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change and percent change in HbA1c at 3, 6 months after administration
Key secondary outcomes
Change and percent change in TC, LDL-C, HDL-C, TG, Scr, microalbuminuria, eGFR, FBS, IRI, HOMA-IR, ApoA1, ApoB, ApoE and SAA at 3, 6, 9, 15 months after administration.
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
Administration of atorvastatin 10mg or rosuvastatin 2.5mg or pitavastatin 2mg in the first 3 months, followed by the administration of pitavastatin 4mg for 12 months.
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) Coronary artery disease patients
Meeting one of following events
1) History of Acute Coronary Syndrome (AMI or Unstable angina)
2) History of revascularization (PCI or CABG)
3) Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification
(2) Hypercholesterolemia patients
Meeting one of following criteria
1) LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians
2) Patents receiving cholesterol lowering drugs
(3) Age (20year old<=)
(4) Patients given written informed consent.
Key exclusion criteria
Exclusion Criteria
1. Patients planed revascularization
2. Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months
3. Patients who have been undergone PCI or CABG within 3 months
4. Malignant tumor in active phase
5. Patients who have hypersensitivity to LIVALO, Lipitor, CRESTOR tablet
6) Patients who have severe liver dysfunction or biliary atresia.
7)Patients who are being treated with cyclosporine
8) Pregnant women, women suspected of being pregnant, or lactating women
9. Patients with prohibited drugs
10. Patients who received insulin therapy.
11. Patients who changed diabetes therapy within 3 months before entry.
12. Patients who received cholesterol-lowering agents except statin within a month before entry.
13. Patients undergoing dialysis
14. Patients with familial hypercholesterolemia
15. Patients who are ineligible in the opinion of the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyakoshi Kazuho |
Organization
Minami-Osaka Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka ,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyakoshi Kazuho |
Organization
Minami-Osaka Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-18-18 Higashikagaya, Suminoe-ku, Osaka ,Japan
TEL
Homepage URL
Sponsor or person
Institute
Minami-Osaka Hospital
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
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
| 2012 | Year | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | 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 | 08 | Month | 06 | Day |
Last modified on
| 2012 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010026
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| Registered date | File name |
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| Registered date | File name |
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