UMIN-CTR Clinical Trial

Basic information
Public title	Qualitative and quantitative effects of aggressive lipid-lowering therapy on atherosclerosis: Evaluation of vulnerable plaque by 64-slice MD-CT
Acronym	Qualitative and quantitative effects of aggressive lipid-lowering therapy on atherosclerosis: Evaluation of vulnerable plaque by 64-slice MD-CT
Scientific Title	Qualitative and quantitative effects of aggressive lipid-lowering therapy on atherosclerosis: Evaluation of vulnerable plaque by 64-slice MD-CT
Scientific Title:Acronym	Qualitative and quantitative effects of aggressive lipid-lowering therapy on atherosclerosis: Evaluation of vulnerable plaque by 64-slice MD-CT
Region	Japan

Condition
Condition	Hypercholesterolemic patients with coronary plaque
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is assess qualitative and quantitative effects of rosuvastatin, a new lipid-lowering drug, on coronary plaques in hypercholesterolemic patients with coronary plaque using 64-slice MD-CT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of CT value of plaque at Week 48
Key secondary outcomes	1)Rate of subjects with low density plaque (CT value <= 50) at Week 48 2)Percentage change of calcium score at Week 48 3)Change of rate of restenosis in blood vessel at Week 48 4)Change of remodeling index at Week 48 5)Percentage change of plaque volume at Week 48 6) Change of lipids (LDL-C, HDL-C, TG, LDL/HDL-C) at Week 48 7) Change of hs-CRP at Week 48 8) Relationship between changes of lipids (LDL-C, HDL-C, LDL-C/HDL-C) and CT value at Week 48

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	Rosuvastatin will be administered for 48 weeks at a dose of 5 mg/day (2 rosuvastatin 2.5 mg tablet or 1 rosuvastatin 5 mg tablet).
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) Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial 2) Patients aged 20 years or older, and no limitations on gender or hospitalization status 3) Patients with calcification score of 0 <
Key exclusion criteria	1) Patients who have received statins within one month before the study entry 2) Patient who doesn't obtain accurate CT value (ex: plaque contains thrombus.) 3) Patients who need to receive other lipid-lowering drugs apart from the test drug 4) Patients with the fasting TG level of more than 400 mg/dL 5) Patients with uncontrolled hypertension (SBP >= 160mmHg or DBP >= 100mmHg) or patients with diabetes (HbA1c >= 8.0%) 6) Patients with familial hypercholesterolemia 7) Patients with secondary hyperlipidemia due to thyroid dysfunction, Cushing's syndrome, nephrotic syndrome, systemic lupus erythematosus, etc. 8) Patients with atrial fibrillation 9) Patients on treatment with cyclosporine 10) Patients currently receiving hemodialysis 11) Patients with a history of serious adverse effects or allergy to HMG-CoA reductase inhibitors 12) Patients with malignant tumor or doubtful malignant tumor, or patients with history of malignant tumor 13) Patients with active liver disease or hepatic dysfunction (ALT, AST, ALP levels more than 2.5 times the upper limit of normal, or a total bilirubin of more than 3.0 mg/dL) 14) Patients with the serum creatinine of more than 1.8 mg/dL 15) Patients with the serum CK level at least 3 times the upper limit of normal 16) Patients who can not take -blockers 17) Patients with confirmed pregnancy, possible pregnancy 18) Patients who underwent coronary PCI 19) Patients who are ineligible for any other reason in the opinion of the investigator
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name katsuomi iwakura
Organization	Sakurabashi Watanabe Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	2-4-32 Umeda, Kita-ku, Osaka
TEL	06-6341-8651
Email

Public contact
Name of contact person	1st name Middle name Last name Yasushi Koyama
Organization	Sakurabashi Watanabe Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	2-4-32 Umeda, Kita-ku, Osaka
TEL	06-6341-8651
Homepage URL
Email	medicine@watanabe-hsp.or.jp

Sponsor
Institute	Sakurabashi Watanabe Hospital
Institute
Department

Funding Source
Organization	JAPAN VASCULAR DISEASE RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	PL Hospital Okamura Memorial Hospital Tokushima Prefectural Central Hospital Ichiriyama Imai Clinic
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	2008 Year 12 Month 26 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	No longer recruiting
Date of protocol fixation	2008 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date	2008 Year 06 Month 01 Day
Last follow-up date	2011 Year 06 Month 01 Day
Date of closure to data entry	2011 Year 06 Month 01 Day
Date trial data considered complete	2011 Year 07 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 12 Month 26 Day
Last modified on	2010 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001924

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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