UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000371
Receipt number 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 16:00:26

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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 or person

Institute

Department of Cardiology, Nagoya University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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