UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031243 |
|---|---|
| Receipt number | R000035670 |
| 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 |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/09/25 08:57:04 |
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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
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
k.tanimura1006@gmail.com
Sponsor or person
Institute
Kobe University,department of cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035670
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