UMIN-CTR Clinical Trial

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

vulnerable plaque in patients with coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

the difference of fibrous cap thickness from baseline

Key secondary outcomes

Study type

Interventional

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

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

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

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

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

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name

Organization

Kobe University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

10

Month

13

Day

Last modified on

2019

Year

06

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030903