UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002160
Receipt number R000002643
Scientific Title A randomized controlled trial comparing anti-postoperative atrial fibrillation effect of landiolol hydrochloride in cardiac surgery for cardiac dysfunvtion
Date of disclosure of the study information 2009/07/03
Last modified on 2014/10/27 13:19:52

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Basic information

Public title

A randomized controlled trial comparing anti-postoperative atrial fibrillation effect of landiolol hydrochloride in cardiac surgery for cardiac dysfunvtion

Acronym

PASCAL trial-II

Scientific Title

A randomized controlled trial comparing anti-postoperative atrial fibrillation effect of landiolol hydrochloride in cardiac surgery for cardiac dysfunvtion

Scientific Title:Acronym

PASCAL trial-II

Region

Japan


Condition

Condition

myocardial infarction, angina, valvular disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the anti-arrhythmic effect of landiolol hydrochloride in patients with arrhythmia after cardiac surgery for cardiac dysfunction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

incidence of postoperative atrial fibrillation

Key secondary outcomes

Cardiac event,MACCE
Cardiac function (UCG)
Blood pressure, heart rate, CVP
BNP, CK-MB, Toronin, HFBP,hs-CRP


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

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intra-and perioperative administration of landiolol hydrochloride

Interventions/Control_2

intra-and perioperative non-administration of landiolol hydrochloride

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Cardia operation
patients from whom informed consent was obtained

Key exclusion criteria

past of arrhythmia
sinus bradycardia at rest (<50/min)
second -or third-degree AV block
clinical hypothyroidism or hyperthyroidism
Doctor's decision not to register to this regimen

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University school of medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan

TEL

03-3972-8111

Email

asezai.med@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Akira Sezai

Organization

Nihon University

Division name

School of Medicine

Zip code


Address

30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo

TEL

03-3972-8111

Homepage URL


Email

asezai.med@gmail.com


Sponsor or person

Institute

Nihon University school of medicine

Institute

Department

Personal name



Funding Source

Organization

self funding

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

2009 Year 07 Month 03 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

2009 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2013 Year 04 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

2009 Year 07 Month 03 Day

Last modified on

2014 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002643


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name