UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001204 |
|---|---|
| Receipt number | R000001469 |
| Scientific Title | Coronary imaging by multislice detector computed tomography in aggressive lipid intervention study (CRYSTAL) |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2008/06/20 13:42:18 |
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Basic information
Public title
Coronary imaging by multislice detector computed tomography in aggressive lipid intervention study (CRYSTAL)
Acronym
Coronary imaging by multislice detector computed tomography in aggressive lipid intervention study (CRYSTAL)
Scientific Title
Coronary imaging by multislice detector computed tomography in aggressive lipid intervention study (CRYSTAL)
Scientific Title:Acronym
Coronary imaging by multislice detector computed tomography in aggressive lipid intervention study (CRYSTAL)
Region
| Japan |
Condition
Condition
Patients with coronary artery disease who underwent PCI
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of aggressive LDL-C lowering therapy in Japanese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the coronary plaque distribution and coronary plaque CT values
Key secondary outcomes
1) Changes in LDL-C, TG, HDL-C
2) Correlation between the absolute and percent changes of LDL-C and changes in the coronary plaque distribution
3) Correlation between the absolute and percent changes of LDL-C and changes in the coronary plaque density
4) Correlation between the absolute and percent changes in the blood test results (lipids, oxidative stress markers, adipocytokines) and changes in the coronary plaque distribution
5) Correlation between the absolute and percent change in the blood test results (lipids, oxidative stress markers, adipocytokines) and changes in the coronary plaque values
6) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, nonfatal MI, PCI or coronary artery bypass grafting, hospitalization due to angina, fatal or nonfatal stroke or TIA)
7) All-cause mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control therapy: Lipid-lowering therapy with 1 to 4 mg pitavastatin daily for a period of 45 months to achieve LDL-C<100mg/dL
Interventions/Control_2
Aggressive therapy: Lipid-lowering therapy with 1 to 4 mg pitavastatin daily for a period of 45 months to achieve LDL-C<70mg/dL
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 receiving lipid-lowering agents; LDL-C>=100mg/dL, patients not receiving lipid-lowering agents; LDL-C>=110mg/dL
2) Patients 20 years or older at the time of provision of consent
3) Patients giving written consent on their own volition for participation in this clinical trial after being provided with sufficient explanation about the study
Key exclusion criteria
1) Patients scheduled to undergo CABG during the treatment period
2) Patients on steroid treatment
3) Non-availability of evaluable CT images
4) Patients with malignant disease
5) Patients on treatment with fibrates or nicotinic acid
6) Patients with a history of hypersensitivity to any of the components of the product
7) Patients with liver dysfunction (AST or ALT values of >=100IU) or the following diseases considered to be associated with biliary obstruction and/or defective hepatic metabolism:
acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus
8) Patients on cyclosporine therapy
9) Pregnant and possibly pregnant women, lactating women
10) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or dialysis patients
11) Patients who are judged by the principal or other investigators to be not eligible for enrollment in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Sumitsuji |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3441
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichi Tachibana |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3441
Homepage URL
tachibana@act.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nozaki Tokushukai Hospital, and Nagoya Tokushukai General Hospital
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 | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2008 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 20 | Day |
Last modified on
| 2008 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001469
