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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029533
Receipt No. R000030903
Scientific Title Efficacy of Alirocumab for Thin-cap fibroatheroma in patients with coronary artery disease estImated by optical coherence tomography trial.
Date of disclosure of the study information 2017/10/13
Last modified on 2019/06/01

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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