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Coronary Artery DiseasePhase 4ALTAIRNCT03552432

The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography

A Phase 4 study testing Alirocumab in people with Coronary Artery Disease and Thin-cap fIbroatheroma, run by Kobe University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Alirocumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteJapan
Study dates
23 Aug 2017to 30 Sep 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who underwent PCI for ACS or stable coronary heart disease
  • Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
  • Patients who have been had TCFA detected by OCT
  • Patients aged ≥20 years old at PCI
  • Patients who agree to be enrolled in the trial giving signed written informed consent

Who cannot join

  • Patients who have been treated previously with at least one dose of any anti-PCSK9 monoclonal antibody
  • Patients had uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) between the time of PCI and randomization visit
  • Known hypersensitivity to alirocumab or rosuvastatin
  • All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
  • Known history of hemorrhagic stroke
  • Currently under treatment for cancer
Show all 10Show fewer
  • Patients on lipoprotein apheresis
  • Patients with severe liver or renal dysfunction
  • Pregnant or breast-feeding women
  • Considered by the investigator as inappropriate for this study for any reason

Trial locations and contacts

1 site in 1 country.

Hiromasa Otake, M.D, Ph,D contact

+81-78-382-5846

hotake@med.kobe-u.ac.jp

Japan1 site, 1 recruiting

  • Kobe University Graduate School of Medicine, Department of Cardiology

    Kobe, Hyōgo, 650-0017

    Hiromasa Otake, MD, +81783825846, hotake@med.kobe-u.ac.jp

    Recruiting

Other trials in Japan

About this study

Official title: The Efficacy of Alirocumab for Thin-cap fIbroatheroma in Patients With Coronary Artery Disease Estimated by Optical Coherence Tomography: Single Center, Randomized, Open-label, Trial

the purpose of this study is to show that alirocumab with statin therapy have a s tronger stabilizing effect on vulnerable plaque in coronary artery disease than statin alone administration

Read the detailed description

The investigators investigate to evaluate the efficacy of alirocumab for vulnerable plaque. The investigators enrolled the patient with standard statin therapy who were detected vulnerable plaque by optical coherence tomography, and categorized into two group; the patients with alirocumab and rosuvastatin were categorized alirocumab therapy group, and the patients with rosuvastatin alone were categorized standard statin therapy group. The investigators compare these two group for outcomes.

Being tested
Alirocumab
Keywords
alirocumab, Thin-cap fIbroatheroma (TCFA), vulnerable plaque, Optical Coherence Tomography (OCT)
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlirocumabDrug

    the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

Study groups in NCT03552432
Study groupRoleWhat they receive
Alirocumab therapy groupExperimentalstart with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day
Receives: Drug: Alirocumab
standard statin therapy groupNo interventionstart with only rosuvastatin 10mg per day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change in fibrous cap thickness

    the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up

    Measured: 9 month

Secondary outcomes (46)

  1. the change in fibrous cap thickness

    the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up

    Measured: 9 month

  2. the change in lipid index

    absolute change in lipid index between baseline and 36-week follow-up

    Measured: 9 month

  3. the change in lipid index

    percentage change in lipid index between baseline and 36-week follow-up

    Measured: 9 month

  4. the change in lipid length,

    absolute change in lipid core length between baseline and 36-week follow-up

    Measured: 9 month

  5. the change in lipid length,

    percentage change in lipid core length between baseline and 36-week follow-up

    Measured: 9 month

  6. the change in mean lipid arc

    absolute change in mean lipid arc between baseline and 36-week follow-up

    Measured: 9 month

  7. the change in mean lipid arc

    percentage change in mean lipid arc between baseline and 36-week follow-up

    Measured: 9 month

  8. the change in max lipid arc

    absolute change in max lipid arc between baseline and 36-week follow-up

    Measured: 9 month

  9. the change in max lipid arc

    percent change in max lipid arc between baseline and 36-week follow-up

    Measured: 9 month

  10. the change in macrophage grade

    absolute change in summation of macrophage grade between baseline and 36-week follow-up.

    macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3

    Measured: 9 month

  11. the change in macrophage grade

    percentage change in summation of macrophage grade between baseline and 36-week follow-up.

    macrophage grade defined as an OCT macrophage grading system to semiquantify the bright spots based on axial and circumferential distribution, as follows: grade 0, no macrophage; grade 1, localized macrophage accumulation; grade 2, clustered accumulation <1 quadrant; grade 3, clustered accumulation >1 quadrant and ≦3 quadrants; and grade 4, clustered accumulation ≧3

    Measured: 9 month

  12. the change in minimum lumen area

    absolute change in minimum lumen area between baseline and 36-week follow-up

    Measured: 9 month

  13. the change in minimum lumen area

    percentage of change in minimum lumen area between baseline and 36-week follow-up

    Measured: 9 month

  14. the number of thin-cap fibroatheroma

    change of the number of thin-cap fibroatheroma at 36-week follow-up

    Measured: 9 month

  15. the change in total cholesterol

    absolute change in serum level of of total cholesterol between baseline and 36-week follow-up

    Measured: 9 month

  16. the change in total cholesterol

    percent change in serum level of of total cholesterol between baseline and 36-week follow-up

    Measured: 9 month

  17. the change in LDL-C

    absolute change in serum level of of LDL-C between baseline and 36-week follow-up

    Measured: 9 month

  18. the change in LDL-C

    percentage change in serum level of of LDL-C between baseline and 36-week follow-up

    Measured: 9 month

  19. the change in HDL-C

    absolute change in serum level of of HDL-C between baseline and 36-week follow-up

    Measured: 9 month

  20. the change in HDL-C

    percentage change in serum level of of HDL-C between baseline and 36-week follow-up

    Measured: 9 month

  21. the change in non-HDL-C

    absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up

    Measured: 9 month

  22. the change in non-HDL-C

    percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up

    Measured: 9 month

  23. the change in apolipoprotein B

    absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up

    Measured: 9 month

  24. the change in apolipoprotein B

    percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up

    Measured: 9 month

  25. the change in Lp(a)

    absolute change in serum level of of Lp (a) between baseline and 36-week follow-up

    Measured: 9 month

  26. the change in Lp(a)

    percentage change in serum level of of Lp (a) between baseline and 36-week follow-up

    Measured: 9 month

  27. the change in hs-CRP

    absolute change in serum level of hs-CRP between baseline and 36-week follow-up

    Measured: 9 month

  28. the change in hs-CRP

    percentage change in serum level of hs-CRP between baseline and 36-week follow-up

    Measured: 9 month

  29. the change in IL-1β

    absolute change in serum level of IL-1β between baseline and 36-week follow-up

    Measured: 9 month

  30. the change in IL-1β

    percentage change in serum level of IL-1β between baseline and 36-week follow-up

    Measured: 9 month

  31. the change in IL-6

    absolute change in serum level of IL-6 between baseline and 36-week follow-up

    Measured: 9 month

  32. the change in IL-6

    percentage change in serum level of IL-6 between baseline and 36-week follow-up

    Measured: 9 month

  33. the change in TNF-α

    absolute change in serum level of TNF-α between baseline and 36-week follow-up

    Measured: 9 month

  34. the change in TNF-α

    percentage change in serum level of TNF-α between baseline and 36-week follow-up

    Measured: 9 month

  35. the change in MCP-1

    absolute change in serum level of MCP-1 between baseline and 36-week follow-up

    Measured: 9 month

  36. the change in MCP-1

    percentage change in serum level of MCP-1 between baseline and 36-week follow-up

    Measured: 9 month

  37. the change in MMP-2

    absolute change in serum level ofMMP-2 between baseline and 36-week follow-up

    Measured: 9 month

  38. the change in MMP-2

    percentage change in serum level ofMMP-2 between baseline and 36-week follow-up

    Measured: 9 month

  39. the change in MMP-9

    absolute change in serum level of MMP-9 between baseline and 36-week follow-up

    Measured: 9 month

  40. the change in MMP-9

    percentage change in serum level of MMP-9 between baseline and 36-week follow-up

    Measured: 9 month

  41. the change in VCAM-1

    absolute change in serum level of VCAM-1between baseline and 36-week follow-up

    Measured: 9 month

  42. the change in VCAM-1

    percentage change in serum level of VCAM-1 between baseline and 36-week follow-up

    Measured: 9 month

  43. the change in ICAM-1

    absolute change in serum level of ICAM-1 between baseline and 36-week follow-up

    Measured: 9 month

  44. the change in ICAM-1

    percentage change in serum level of ICAM-1 between baseline and 36-week follow-up

    Measured: 9 month

  45. the change in free PCSK9

    absolute change in serum level of free PCSK9 between baseline and 36-week follow-up

    Measured: 9 month

  46. the change in free PCSK9

    percentage change in serum level of free PCSK9 between baseline and 36-week follow-up

    Measured: 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start23 Aug 2017
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552432
Sponsor's protocol ID
KobeU-290017
Acronym
ALTAIR
Status last verified
Nov 2018
First submitted
7 May 2018
Last updated
14 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Otake H, Sugizaki Y, Toba T, Nagano Y, Tsukiyama Y, Yanaka KI, Yamamoto H, Nagasawa A, Onishi H, Takeshige R, Nakano S, Matsuoka Y, Tanimura K, Kawamori H, Shinke T, Hirata KI. Efficacy of alirocumab for reducing plaque vulnerability: Study protocol for ALTAIR, a randomized controlled trial in Japanese patients with coronary artery disease receiving rosuvastatin. J Cardiol. 2019 Mar;73(3):228-232. doi: 10.1016/j.jjcc.2018.11.012. Epub 2018 Dec 19.

    PubMed 30579806

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alirocumab in people with Coronary Artery Disease and Thin-cap fIbroatheroma, run by Kobe University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hiromasa Otake, M.D, Ph,D (+81-78-382-5846, hotake@med.kobe-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change in fibrous cap thickness (time frame: 9 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.

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