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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000000582
Receipt No. R000000693
Scientific Title Collaborative Trial of Fluvastatin on Atrial Fibrillation
Date of disclosure of the study information 2007/01/31
Last modified on 2007/01/25

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Basic information
Public title Collaborative Trial of Fluvastatin on Atrial Fibrillation
Acronym CO-FAT study
Scientific Title Collaborative Trial of Fluvastatin on Atrial Fibrillation
Scientific Title:Acronym CO-FAT study
Region
Japan

Condition
Condition paroxysmal atrial fibrillation or transient atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether fluvastatin maintains sinus rhythm after electrical or pharmacological cardioconversion in transient Af and prevents occurrence of Af in paroxysmal Af.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes 1) maintenance of sinus rhythm
2) frequency of atrial fibrillation occurrence
Key secondary outcomes 1) new onset or recurrence of brain attack (including TIA)
2) hospitalization due to heart failure
3) other cardiovascular events
4) other adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 fluvastatin add-on therapy
Interventions/Control_2 conventional therapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient who has either of the following atrial fibrillations:
(1) paroxysmal atrial fibrillation (frequency of Af attack: over 2 times per month)
(2) transient atrial fibrillation planned cardiovaersion
2) Outpatients aged over 20 years, regardless of sex
3) regardless of medication on atrial fibrillation
3) Total cholesterol over 220 mg/dL or LDL-cholesterol less than 140 mg/dL
Key exclusion criteria 1) patients who underwent catheter ablation within 3 months
2) patients who underwent cardiac surgery within 1 month
3) patients with a history of cerebrovascular disorder or myocardial infarction within 1 month
4) patients with severe heart failure
5) patients with dialysis or severe renal dysfunction
6) patients with severe liver dysfunction
7) other patients who are judged to be inappropriate for the study by the investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aonuma
Organization University of Tsukuba, Graduate School of Comprehensive Human Science
Division name Department of Cardiology
Zip code
Address 1-1-1, Ten-noudai, Tsukuba, 305-8577, Japan
TEL 029-853-2991
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sachio Sekiguchi
Organization University of Tsukuba, Graduate School of Comprehensive Human Science
Division name Department of Cardiology
Zip code
Address 1-1-1, Ten-noudai, Tsukuba, 305-8577, Japan
TEL 029-853-2991
Homepage URL
Email

Sponsor
Institute CO-FAT study group
Institute
Department

Funding Source
Organization
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
2007 Year 01 Month 31 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 Preinitiation
Date of protocol fixation
2006 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2008 Year 08 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
2007 Year 01 Month 25 Day
Last modified on
2007 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000693

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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