UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006026
Receipt number R000007132
Scientific Title Effects of anti-viral drug (vidarabine) on atrial fibrillation and ventricular arrhythmia
Date of disclosure of the study information 2011/08/01
Last modified on 2020/03/02 10:08:08

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Basic information

Public title

Effects of anti-viral drug (vidarabine) on atrial fibrillation and ventricular arrhythmia

Acronym

Treatment of arrhythmia by vidarabine

Scientific Title

Effects of anti-viral drug (vidarabine) on atrial fibrillation and ventricular arrhythmia

Scientific Title:Acronym

Treatment of arrhythmia by vidarabine

Region

Japan


Condition

Condition

Arrhythmia

Classification by specialty

Medicine in general Cardiology Surgery in general
Pediatrics Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Vidarabine is used as an anti-viral drug for many years. Vidarabine was demonstrated to inhibit cardiac adenylyl cyclase activity. Recently, it has been demonstrated to be beneficial for the treatment of arrhythmia such as atrial fibrillation and ventricular arrhythmia. We will examine the effects of vidarabine on these arrhythmia in human.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Time to terminate the atrial fibrillation
2) The decrease number of ventricular arrhythmia

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is 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

Effects for atrial arrhythmia

Interventions/Control_2

Effects for ventricular arrhythmia

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

0 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Afrial fibrillation
Ventricular arrhythmia

Key exclusion criteria

Central nervous disease
Severe liver dysfunction
Severe renal dysfunction

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Okumura, Yoshihiro Ishikawa

Organization

Yokohama City University

Division name

Cardiovascular Research Institute

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan, 236-0004

TEL

045-787-2575

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiro Ichikawa

Organization

Yokohama City University

Division name

Cardiovascular Research Institute

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan, 236-0004

TEL

045-787-2575

Homepage URL

http://www-user.yokohama-cu.ac.jp/~seiri1/index.html

Email

junseiri@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University,Cardiovascular Research Institute

Institute

Department

Personal name



Funding Source

Organization

Cardiovascular Research Institute, Yokohama City University

Organization

Division

Category of Funding Organization

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

2011 Year 08 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

Completed

Date of protocol fixation

2011 Year 08 Month 01 Day

Date of IRB

2011 Year 06 Month 01 Day

Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2015 Year 03 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 07 Month 22 Day

Last modified on

2020 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007132


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name