UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015802 |
|---|---|
| Receipt number | R000016854 |
| Scientific Title | Impact of the Landiolol on the level on serum biomarkers, catecholamines and cardiac enzymes in patients with coronary artery disease performed percutaneouse coronary intervention. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2021/08/28 15:52:01 |
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Basic information
Public title
Impact of the Landiolol on the level on serum biomarkers, catecholamines and cardiac enzymes in patients with coronary artery disease performed percutaneouse coronary intervention.
Acronym
Impact of the Landiolol on the level on serum biomarkers, catecholamines and cardiac enzymes in patients with coronary artery disease performed percutaneouse coronary intervention.
Scientific Title
Impact of the Landiolol on the level on serum biomarkers, catecholamines and cardiac enzymes in patients with coronary artery disease performed percutaneouse coronary intervention.
Scientific Title:Acronym
Impact of the Landiolol on the level on serum biomarkers, catecholamines and cardiac enzymes in patients with coronary artery disease performed percutaneouse coronary intervention.
Region
| Japan |
Condition
Condition
angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of Landiolol (beta-1 selective blocker) on serum biomarkers, catecholamines and cardiac enzymes in patients with coronary artery disease performing percutaneouse coronary intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between Landiolol group and non-Landiolol group on serum adiponectine and high molecular weight adiponectine 72 hours after percutaneous coronary intervention
Key secondary outcomes
Serum catecholamines level.Serum troponine level
Hypotension, A-block, bradycardia and worsening heart failure while using Landiolol.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Landiolol group
Landiolol is started 15 minutes before percutaneous coronary intervention, which dose is 3 mcg/kg/min. Its injection will continue until the next day morning.
Interventions/Control_2
Non Landiolo group
Normal sarine is started 15 minutes before percutaneous coronary intervention, which dose is 10mL/hour. Its injection will continue until the next day morning.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with angina pectoris who will be scheduled percutaneous coronary intervention.
Key exclusion criteria
1. HR less than 50bpm
2. 2or3 AV block
3. Shock
4. Left main disease
5. Asthma
6. Right ventricular infarction
7. History of side effects by using beta blockers
8. Symptom of heart failure
9. Patients with malignancy, uncontrolled infection
10. Patients who need hemodialysis
11. PCI for chronic total occlusion
12. Reduced ejection fraction (<40%)
13. Pregnant
14. Patients who used Landiolol within 1 month before PCI
15. Not eligible determined by the responding physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kiyokuni |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanagawa-ku, Yokohama
TEL
045-787-2800
masakiyo@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kiyokuni |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanagawa-ku, Yokohama
TEL
045-787-2800
Homepage URL
masakiyo@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine
Yokohama City University Graduate 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
Yokohama City University
Address
3-9 Fukuura, Kanagawa-ku, Yokohama
Tel
045-787-2800
rinri@yokohama-cu.ac.jp
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00380-020-01637-6
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00380-020-01637-6
Number of participants that the trial has enrolled
70
Results
Serum APN and HMW-APN level 3 days after PCI were similar between patients treated with and without landiolol. APN and HMW-APN decreased 1 day after PCI in the SAP and landiolol mitigated decrease in HMW-APN.
Results date posted
| 2021 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We recruited 70 patients with SAP.
Participant flow
We recruited 70 patients with SAP and randomized them to intravenous landiolol during PCI (N = 35) or control group (N = 35).
Adverse events
No adverse events were observed.
Outcome measures
The primary endpoint was serum APN and HMW-APN level 3 days after PCI.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016854
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