UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial comparing anti-arrhythmic effect of landiolol hydrochloride in cardiac surgery
Title of the study (Brief title)	PASCAL trial
Region	Japan

Condition
Condition	myocardial infarction, angina, valvular disease, thoracic aortic aneurysm, arrhythmia
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
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of postoperative arrhythmia
Key secondary outcomes	1) age 2) Blood pressure, heart rate, CVP 3) hyaluronan, KL-6, ANP, BNP, angiotensin-II

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
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	patients from whom informed consent was obtained
Key exclusion criteria	cardiogenic shock 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	200

Research contact person
Name of lead principal investigator	Akira Sezai
Organization	Nihon University school of medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	Akira Sezai
Organization	Nihon University school of medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	asezai.med@gmail.com

Sponsor
Institute	Nihon University school of medicine
Institute
Department

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)

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	2008 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 01 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2011 Year 09 Month 01 Day
Date of closure to data entry	2011 Year 09 Month 01 Day
Date trial data considered complete	2011 Year 09 Month 01 Day
Date analysis concluded	2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 10 Month 20 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001750