![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000001602 |
Receipt No. | 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 |
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 |
|
Condition | ||
Condition | Hypercholesterolemic patients with coronary plaque | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |