UMIN-CTR Clinical Trial

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
Email	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
Email	masakiyo@yokohama-cu.ac.jp

Sponsor
Institute	Department of Medical Science and Cardiorenal Medicine Yokohama City University Graduate 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)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura, Kanagawa-ku, Yokohama
Tel	045-787-2800
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016854