UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010560
Receipt number R000012275
Scientific Title Research on the preventive effect of the atrial fibrillation by febuxostat
Date of disclosure of the study information 2014/04/01
Last modified on 2013/04/22 14:00:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Research on the preventive effect of the atrial fibrillation by febuxostat

Acronym

Research on the preventive effect of the atrial fibrillation by febuxostat

Scientific Title

Research on the preventive effect of the atrial fibrillation by febuxostat

Scientific Title:Acronym

Research on the preventive effect of the atrial fibrillation by febuxostat

Region

Japan


Condition

Condition

Paroxysmal atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpuse of this research is verifing whether febuxostat prevent the incidence of atrial fibrilation via reduction of cardiac oxidative stress

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reduction of incidence of atrial fibrillation
Shortning of duration of atrial fibrillation

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

(a) Hyperuricemia (serum urinaric acid level is over 7.0 mg/dl)
(b) The patient with apparent attakck of paroxysmal atrial fibrillation
(c) The patient aged 20 and over in the time of consent acquisition
(d) The document consent by a free intention was obtained.
(e) An outpatient and an inpatient

Key exclusion criteria

(a) persistent and permanent AF
(b) The patient who was new-prescribed in an ACE inhibitor or ARB within six months recently. A patient who had the quantity of an ACE inhibitor or ARB increased within six months.
(c) The patient who has mitral stenosis more than the degree of moderate class
(d) The patient who received catheter ablation during less than three months or research period.
(e) The patient already medicated with allopurinol.
(f) A patient with the past of the hypersensitivity to the medicine
(g)The patient who has liver disease (AST or ALT >100U)
(h)The patient who has a severe renal failure (BUN >30mg/dL, Serum creatinin >2.5mg/dL)
(i) The patient under administration of azathioprine, vidarabine and didanosine (contraindications)
(j) A woman under pregnancy or with the possibility of pregnancy
(k) The woman under breast-feeding
(l) The patient who received medication of other trial drugs within three months before the medication
(m) In addition, the patient who judged that a chief (assignment) researcher was unsuitable as a subject

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotaka Yada

Organization

National defense medical college

Division name

Cardiology

Zip code


Address

3-2 Namiki, Tokorozawa, Saitama, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

National defense medical college

Division name

Cardiology

Zip code


Address


TEL

04-2995-1511

Homepage URL


Email



Sponsor or person

Institute

Cardiology, National defense medical college

Institute

Department

Personal name



Funding Source

Organization

TEIJIN PHARMA

Organization

Division

Category of Funding Organization

Other

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

防衛医科大学校病院 (埼玉県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 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

Enrolling by invitation

Date of protocol fixation

2012 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We check blood pressure, pulse rate, blood test, a urine test, chest X-rays, 12 leads electrocardiogram, UCG, the Holter electrocardiogram, and all the efficacy evaluation items of the questionnaire of an arrhythmic attack at the time of a medical treatment start, 6 or 12 months.


Management information

Registered date

2013 Year 04 Month 22 Day

Last modified on

2013 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012275


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name