UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000957 |
|---|---|
| Receipt number | 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 10:35:31 |
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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
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
kim-nms@umin.net
Sponsor or person
Institute
JL-Knight Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001150
