UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000582 |
|---|---|
| Receipt number | 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 12:11:53 |
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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
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
Sponsor or person
Institute
CO-FAT study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000693
