UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001602 |
|---|---|
| Receipt number | R000001924 |
| Scientific Title | Qualitative and quantitative effects of aggressive lipid-lowering therapy on atherosclerosis: Evaluation of vulnerable plaque by 64-slice MD-CT |
| Date of disclosure of the study information | 2008/12/26 |
| Last modified on | 2010/07/06 14:15:38 |
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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
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
medicine@watanabe-hsp.or.jp
Sponsor or person
Institute
Sakurabashi Watanabe Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001924
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