UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003824 |
|---|---|
| Receipt number | 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 14:07:28 |
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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
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
yujiokuyama@hotmail.com
Sponsor or person
Institute
Osaka General Medical Center
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004607
