UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Alirocumab(proprotein convertase subtilisin/kexin type9 inhibitor) and Rosuvastatin or Rosuvastatin alone on lipid core plaques in coronary artery disease evaluated by near-infrared spectroscopy intravascular ultrasound
Acronym	ANTARES
Scientific Title	Effect of Alirocumab(proprotein convertase subtilisin/kexin type9 inhibitor) and Rosuvastatin or Rosuvastatin alone on lipid core plaques in coronary artery disease evaluated by near-infrared spectroscopy intravascular ultrasound
Scientific Title:Acronym	ANTARES
Region	Japan

Condition
Condition	angina pectoris
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alilocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS test at the time of PCI and treatment evaluation (week 36) in the group of Alirocumab and standard treatment (statin alone).
Key secondary outcomes	LCBI(lesion), Angle of lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Alirocumab 75mg/2week+Rosuvastatin 5mg/daily during 9 months
Interventions/Control_2	Rosuvastatin 10mg/daily alone during 9 months
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	In patients undergoing PCI with ACS or stable angina, stenosis of 25-75% on CAG remained after PCI and maxLCBI(4mm) was over 400 in patients who could analyze NIRS-IVUS images.
Key exclusion criteria	Patients who have received one or more doses of anti-PCSK9 monoclonal antibody. Patients who experienced poorly controlled high blood pressure (systolic blood pressure>180 mmHg or diastolic blood pressure>110 mmHg measured more than once) between the time of PCI and randomization. Patients with LDL-Chol value <70 mg/dl. Patients with allergic drug hypersensitivity to drugs to be used. Patients with a history of hemorrhagic stroke. Patients receiving treatment for anticancer drugs. Patients undergoing LDL apheresis. Patients with serious liver and kidney dysfunction. Patients who conflict with any of the warning contraindications listed in the Rosuvastatin national package insert. Patients contradicting the contraindications listed in the Pralient's national package insert. Pregnant women and pregnant or lactating patients. Others Patients judged inappropriate by the doctor in charge of this exam.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Otake Hiromasa
Organization	Kobe University Hospital
Division name	cardiology
Zip code
Address	7-5-2, Kusunokicho, Chuouku, Kobe city, Hyogo prefecture
TEL	078-382-5846
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tanimura Kosuke
Organization	Kobe University Hospital
Division name	Cardiology
Zip code
Address	7-5-2, Kusunokicho, Chuouku, Kobe city, Hyogo prefecture
TEL	078-382-5846
Homepage URL
Email	k.tanimura1006@gmail.com

Sponsor
Institute	Kobe University,department of cardiology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 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	Terminated
Date of protocol fixation	2018 Year 03 Month 01 Day
Date of IRB	2020 Year 07 Month 06 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2020 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 10 Day
Last modified on	2020 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035670