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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003824
Receipt No. R000004607
Scientific Title Assessment of Atrial Late Potentials in Patients with Hypercholesterolemia, to Investigate the Preventive Effect of Pitavastatin on Atrial Fibrillation.
Date of disclosure of the study information 2010/06/25
Last modified on 2011/03/01

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Basic information
Public title Assessment of Atrial Late Potentials in Patients with Hypercholesterolemia,
to Investigate the Preventive Effect of Pitavastatin on Atrial Fibrillation.
Acronym Assessment of Atrial Late Potentials in Patients with Hypercholesterolemia,
to Investigate the Preventive Effect of Pitavastatin on Atrial Fibrillation.
Scientific Title Assessment of Atrial Late Potentials in Patients with Hypercholesterolemia,
to Investigate the Preventive Effect of Pitavastatin on Atrial Fibrillation.
Scientific Title:Acronym Assessment of Atrial Late Potentials in Patients with Hypercholesterolemia,
to Investigate the Preventive Effect of Pitavastatin on Atrial Fibrillation.
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are to evaluate the protective effect of pitavastatin on the substrate of atrial fibrillation, using P wave signal-averaged ECG.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Change in atrial late potentials recorded by P wave signal-averaged ECG.
Key secondary outcomes 1. Correlation between baseline characteristics and atrial late potentials.

2. Correlation between change in atrial late potentials and change in blood biomarkers.

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin 1-4 mg daily for a period of 12 months
Interventions/Control_2 Non-statin treatment initially using ezetimibe 10 mg daily for a period of 12 months
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with hypercholesterolemia who have not attained the target LDL-C level established by the Japan Atherosclerosis Society guidelines for prevention of atherosclerotic cardiovascular diseases (2007).

2. 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 who have a contraindication to LIVALO TAB administration.

2. Patients who have a contraindication to Zetia administration .

3. Patients who have a contraindication to LIPIDIL CAPSULE or Tricor Capsule administration.

4. Patients with liver dysfunction (AST or ALT values of >=100IU).

5. Patients being treated with statins.

6. Patients who are judged by the investigator to be not eligible for enrollment in the study.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Okuyama
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
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Okuyama
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
Email yujiokuyama@hotmail.com

Sponsor
Institute Osaka General Medical Center
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 大阪府立急性期・総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 25 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 No longer recruiting
Date of protocol fixation
2008 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 25 Day
Last modified on
2011 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004607

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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