UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.
Acronym	ALTAIR trial
Scientific Title	Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.
Scientific Title:Acronym	ALTAIR trial
Region	Japan

Condition
Condition	vulnerable plaque in patients with coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the purpose of this study is to show that alirocumab with statin therapy have a stronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the difference of fibrous cap thickness from baseline
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in the alirocumab arm will receive subcutaneous alirocumab 75 mg every 2 weeks (Q2W) in addition to statin therapy (rosuvastatin 10 mg/day).
Interventions/Control_2	Patients in the standard-of-care arm will receive rosuvastatin 10 mg/day, with initiation and/or dose adjustment of non-statin lipid-lowering drugs to achieve an LDL-C target <70 mg/dL
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	ALTAIR employs the following eligibility criteria: 1: Patients who underwent PCI for ACS or stable coronary heart disease 2: Patients who have been treated stain therapy or who have been started statin therapy after PCI 3: Patients who have been detected TCFA by OCT at PCI 4: Patients aged more than or equal 20 years old at PCI 5: Patients who agree to be enrolled in the trial giving signed written informed consent
Key exclusion criteria	Exclusion criteria are follows; 1: Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody 2: Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit 3: Patients with LDL-C <70 mg/dL 4: Known hypersensitivity to alirocumab or rosuvastatin 5: Known history of hemorrhagic stroke 6: Currently under treatment for cancer 7: Patients on lipoprotein apheresis 8: Patients with severe liver or renal dysfunction 9: All contraindications to rosuvastatin as displayed in the respective national product labeling for these treatments 10: All contraindications to alirocumab as displayed in the respective national product labeling for these treatments 11: Pregnant or breast-feeding women 12: Considered by the investigator as inappropriate for this study for any reason
Target sample size	24

Research contact person
Last name of lead principal investigator	1st name Hiromasa Middle name Last name Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5846
Email	hotake@med.kobe-u.ac.jp

Public contact
1st name of contact person	1st name Yoichiro Middle name Last name Sugizaki
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL	+81-78-382-5846
Homepage URL
Email	catheg@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine
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	Kobe university hospital clinical research centor
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel	078-382-6669
Email	ccrspprt@med.kobe-u.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

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 13 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	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 13 Day
Last modified on	2019 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030903