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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008627
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Minami-Osaka Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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