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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000957
Receipt No. R000001150
Scientific Title Clinical study of Landiolol hydrochloride in the treatment of postoperative atrial fibrillation/atrial flutter after cardiovascular surgery
Date of disclosure of the study information 2007/12/27
Last modified on 2010/01/14

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Basic information
Public title Clinical study of Landiolol hydrochloride in the treatment of postoperative atrial fibrillation/atrial flutter after cardiovascular surgery
Acronym JL-Knight Study
(Japan Landiolol-Kicking off the novel investigation for gold standard heart study)
Scientific Title Clinical study of Landiolol hydrochloride in the treatment of postoperative atrial fibrillation/atrial flutter after cardiovascular surgery
Scientific Title:Acronym JL-Knight Study
(Japan Landiolol-Kicking off the novel investigation for gold standard heart study)
Region
Japan

Condition
Condition tachyarrhythmia
Classification by specialty
Cardiology Anesthesiology Cardiovascular surgery
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of beta-blocker,Landiolol hydrochloride versus calcium channel blocker,Diltiazem hydrochloride are compared in the treatment of postoperative atrial fibrillation/atrial flutter after cardiovascular surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Atrial fibrillation / atrial flutter (heart rate control, converting rate to normal sinus rhythm, palindromia rate)
Key secondary outcomes Ischemic changes
Changes of blood pressure
Manifestation rate of bradycardia,atrioventricular block and cardiovascular events
Length of ICU and hospitalization
Cost of medical care after cardiovascular surgery
Mortality rate in nosocomial

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous beta-blocker, Landiolol hydrochloride for up to 24 hrs
Interventions/Control_2 Intravenous calcium channel blocker, Diltiazem hydrochloride for up to 24 hrs
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients after cardiovascular surgery
*postoperative atrial fibrillation / atrial flutter with a ventricular rate more than or equal to 110 b.p.m. for a duration more than or equal to 5 min within 7 days after surgery
Key exclusion criteria (1) acute myocardial infarction within 3 days
(2) supraventricular arrhythmia
(3) sick sinus syndrome (containing patients with pacemaker)
(4) grave heart failure (preoperative NYHA Classification of the Stages of Heart Failure, more than or equal to third degree)
(5) atrioventricular block, more than or equal to second degree
(6) contraindication to beta-blockers or , calcium channel blockers
(7) electrolyte imbalance, WPW syndrome or hyperthyroidism
(8) blood pressure < 90/60 mmHg
(9) postoperative peroral use of beta-blockers or, calcium channel blockers
(10) use of operative and postoperative antiarrhythmic medications excluding Digitalis
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Sakamoto
Organization Nippon Medical School
Division name Department of Anesthesiology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL 03-5814-6243
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chol Kim
Organization Nippon Medical School
Division name Department of Anesthesiolgy
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL 03-5814-6243
Homepage URL
Email kim-nms@umin.net

Sponsor
Institute JL-Knight Study Group
Institute
Department

Funding Source
Organization none
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
2007 Year 12 Month 27 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
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 01 Month 01 Day
Date trial data considered complete
2010 Year 02 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 26 Day
Last modified on
2010 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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