UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002829 |
|---|---|
| Receipt number | R000003446 |
| Scientific Title | Myocardial ischemia treated with PCI and coronary plaque regression induced by lipid lowering and blood pressure controlling assessed by intravascular ultrasonography |
| Date of disclosure of the study information | 2010/02/10 |
| Last modified on | 2015/06/02 14:24:28 |
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Basic information
Public title
Myocardial ischemia treated with PCI and coronary plaque regression induced by lipid lowering and blood pressure controlling assessed by intravascular ultrasonography
Acronym
Myocardial ischemia treated with PCI and coronary plaque regression induced by lipid lowering and blood pressure controlling assessed by intravascular ultrasonography
Scientific Title
Myocardial ischemia treated with PCI and coronary plaque regression induced by lipid lowering and blood pressure controlling assessed by intravascular ultrasonography
Scientific Title:Acronym
Myocardial ischemia treated with PCI and coronary plaque regression induced by lipid lowering and blood pressure controlling assessed by intravascular ultrasonography
Region
| Japan |
Condition
Condition
Patients with coronary artery disease accompanied with hypertension and hypercholesterolemia treated with percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the changes of coronary plaque volume after hypotensive and hypocholesterolemic therapy by intravascular ultrasonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of coronary plaque volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention 1:aggressive intervention(target blood pressure<120/70mmHg, target LDL-C<70mg/dl)
starting dose of atorvastatin 10mg
starting dose of amrodipine 5mg
Interventions/Control_2
Intervention 2:standard intervention(target blood pressure<140/90mmHg, target LDL-C<100mg/dl)
starting dose of atorvastatin 5mg
starting dose of amrodipine 2.5mg
Interventions/Control_3
18 months
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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypercholesterolemia(greater than 100mg/dl)(with or without hypolipidemic drug therapy)
Successful PCI
At least 1 coronary plaque except for target lesion for PCI
Key exclusion criteria
Unsuccessful PCI
Cardiogenic shock
Type 1 diabetes mellitus
Diabetes mellitus under insulin injection therapy or poor control
Secondary hypertension
Dihydropyridine Calcium channel blocker user for more than 6 months
Statin user stronger than 10 mg daily of atorvastatin (pitavastatin, rosuvastatin)
Familial hypercholesterolemia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masa-aki Kawashiri |
Organization
Kanazawa University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2251
mk@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masa-aki Kawashiri |
Organization
Kanazawa University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2251
Homepage URL
mk@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medicine, Division of Cardiovascular 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
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
| 2010 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24895097
Publication of results
Partially published
Result
URL related to results and publications
http://www.clinicaltrialresults.org/Slides/SCAI2015/Kawashiri_Million-Study.pdf
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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 04 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 02 | Day |
Last modified on
| 2015 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
