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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000371
Receipt No. R000000471
Scientific Title Effects of Atorvastatin on Reducing F-FDG Accumulation in Atherosclerotic Plaques: Using PET Imaging Study: pilot phase
Date of disclosure of the study information 2006/09/01
Last modified on 2010/09/27

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Basic information
Public title Effects of Atorvastatin on Reducing F-FDG Accumulation in Atherosclerotic Plaques: Using PET Imaging Study: pilot phase
Acronym EARDROP Study
Scientific Title Effects of Atorvastatin on Reducing F-FDG Accumulation in Atherosclerotic Plaques: Using PET Imaging Study: pilot phase
Scientific Title:Acronym EARDROP Study
Region
Japan

Condition
Condition Patients with hyperlipidemia, who are going to undergo percutaneous coronary intervention for treatment of stable angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To detect the efficacy of low and high doses of atorvastatin for reducing F-FDG accumulations in atherosclerotic plaques in patients with stable angina pectoris, undergoing percutaneous coronary intervention (PCI) using F-FDG-PET
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the F-FDG-accumulation rate (plaque/integral plasma) at 6 months after PCI from baseline (both absolute value and % changes)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patients are given low doses (5 mg/day) atorvastatin for 6 months, starting immediately after PCI
Interventions/Control_2 Patients are given high doses (20 mg/day) atorvastatin for 6 months, starting immediately after PCI
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
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Patients with hyperlipidemia who are taking elective PCI
Key exclusion criteria 1)Patients with impaired glucose tolerance or diabetes mellitus
2)Patients with serum Cr>2mg/dl
3)Patients with acute coronary syndrom
4)Patients who are treated with any lipid-lowering drugs (statins, fibrates and/or nicotinic acid) before enrollment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ishii
Organization Nagoya University School of Medicine
Division name Department of Cardiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya University School of Medicine
Division name Department of Cardiology
Zip code
Address
TEL
Homepage URL
Email y-ogawa@med.nagoya-u.ac.jp

Sponsor
Institute Department of Cardiology, Nagoya University School of Medicine
Institute
Department

Funding Source
Organization Self funding
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
2006 Year 09 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 Completed
Date of protocol fixation
2006 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2010 Year 03 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
2006 Year 03 Month 27 Day
Last modified on
2010 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000471

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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