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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002829
Receipt No. 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

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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
Email 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
Email mk@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Graduate School of Medicine, Division of Cardiovascular Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003446

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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