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

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ClinicalTrials.gov Identifier: NCT03552432
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hiromasa Otake, Kobe University

Brief 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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Thin-cap fIbroatheroma Drug: Alirocumab Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: Alirocumab therapy group
start with alirocumab 75mg per 2weeks and rosuvastatin 10mg per day
Drug: Alirocumab
the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months

No Intervention: standard statin therapy group
start with only rosuvastatin 10mg per day



Primary Outcome Measures :
  1. the change in fibrous cap thickness [ Time Frame: 9 month ]
    the absolute change in minimum fibrous-cap thickness between baseline and 36-week follow-up


Secondary Outcome Measures :
  1. the change in fibrous cap thickness [ Time Frame: 9 month ]
    the percent change in minimum fibrous-cap thickness between baseline and 36-week follow-up

  2. the change in lipid index [ Time Frame: 9 month ]
    absolute change in lipid index between baseline and 36-week follow-up

  3. the change in lipid index [ Time Frame: 9 month ]
    percentage change in lipid index between baseline and 36-week follow-up

  4. the change in lipid length, [ Time Frame: 9 month ]
    absolute change in lipid core length between baseline and 36-week follow-up

  5. the change in lipid length, [ Time Frame: 9 month ]
    percentage change in lipid core length between baseline and 36-week follow-up

  6. the change in mean lipid arc [ Time Frame: 9 month ]
    absolute change in mean lipid arc between baseline and 36-week follow-up

  7. the change in mean lipid arc [ Time Frame: 9 month ]
    percentage change in mean lipid arc between baseline and 36-week follow-up

  8. the change in max lipid arc [ Time Frame: 9 month ]
    absolute change in max lipid arc between baseline and 36-week follow-up

  9. the change in max lipid arc [ Time Frame: 9 month ]
    percent change in max lipid arc between baseline and 36-week follow-up

  10. the change in macrophage grade [ Time Frame: 9 month ]

    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


  11. the change in macrophage grade [ Time Frame: 9 month ]

    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


  12. the change in minimum lumen area [ Time Frame: 9 month ]
    absolute change in minimum lumen area between baseline and 36-week follow-up

  13. the change in minimum lumen area [ Time Frame: 9 month ]
    percentage of change in minimum lumen area between baseline and 36-week follow-up

  14. the number of thin-cap fibroatheroma [ Time Frame: 9 month ]
    change of the number of thin-cap fibroatheroma at 36-week follow-up

  15. the change in total cholesterol [ Time Frame: 9 month ]
    absolute change in serum level of of total cholesterol between baseline and 36-week follow-up

  16. the change in total cholesterol [ Time Frame: 9 month ]
    percent change in serum level of of total cholesterol between baseline and 36-week follow-up

  17. the change in LDL-C [ Time Frame: 9 month ]
    absolute change in serum level of of LDL-C between baseline and 36-week follow-up

  18. the change in LDL-C [ Time Frame: 9 month ]
    percentage change in serum level of of LDL-C between baseline and 36-week follow-up

  19. the change in HDL-C [ Time Frame: 9 month ]
    absolute change in serum level of of HDL-C between baseline and 36-week follow-up

  20. the change in HDL-C [ Time Frame: 9 month ]
    percentage change in serum level of of HDL-C between baseline and 36-week follow-up

  21. the change in non-HDL-C [ Time Frame: 9 month ]
    absolute change in serum level of of non-HDL-C between baseline and 36-week follow-up

  22. the change in non-HDL-C [ Time Frame: 9 month ]
    percentage change in serum level of of non-HDL-C between baseline and 36-week follow-up

  23. the change in apolipoprotein B [ Time Frame: 9 month ]
    absolute change in serum level of of apolipoprotein B between baseline and 36-week follow-up

  24. the change in apolipoprotein B [ Time Frame: 9 month ]
    percentage change in serum level of of apolipoprotein B between baseline and 36-week follow-up

  25. the change in Lp(a) [ Time Frame: 9 month ]
    absolute change in serum level of of Lp (a) between baseline and 36-week follow-up

  26. the change in Lp(a) [ Time Frame: 9 month ]
    percentage change in serum level of of Lp (a) between baseline and 36-week follow-up

  27. the change in hs-CRP [ Time Frame: 9 month ]
    absolute change in serum level of hs-CRP between baseline and 36-week follow-up

  28. the change in hs-CRP [ Time Frame: 9 month ]
    percentage change in serum level of hs-CRP between baseline and 36-week follow-up

  29. the change in IL-1β [ Time Frame: 9 month ]
    absolute change in serum level of IL-1β between baseline and 36-week follow-up

  30. the change in IL-1β [ Time Frame: 9 month ]
    percentage change in serum level of IL-1β between baseline and 36-week follow-up

  31. the change in IL-6 [ Time Frame: 9 month ]
    absolute change in serum level of IL-6 between baseline and 36-week follow-up

  32. the change in IL-6 [ Time Frame: 9 month ]
    percentage change in serum level of IL-6 between baseline and 36-week follow-up

  33. the change in TNF-α [ Time Frame: 9 month ]
    absolute change in serum level of TNF-α between baseline and 36-week follow-up

  34. the change in TNF-α [ Time Frame: 9 month ]
    percentage change in serum level of TNF-α between baseline and 36-week follow-up

  35. the change in MCP-1 [ Time Frame: 9 month ]
    absolute change in serum level of MCP-1 between baseline and 36-week follow-up

  36. the change in MCP-1 [ Time Frame: 9 month ]
    percentage change in serum level of MCP-1 between baseline and 36-week follow-up

  37. the change in MMP-2 [ Time Frame: 9 month ]
    absolute change in serum level ofMMP-2 between baseline and 36-week follow-up

  38. the change in MMP-2 [ Time Frame: 9 month ]
    percentage change in serum level ofMMP-2 between baseline and 36-week follow-up

  39. the change in MMP-9 [ Time Frame: 9 month ]
    absolute change in serum level of MMP-9 between baseline and 36-week follow-up

  40. the change in MMP-9 [ Time Frame: 9 month ]
    percentage change in serum level of MMP-9 between baseline and 36-week follow-up

  41. the change in VCAM-1 [ Time Frame: 9 month ]
    absolute change in serum level of VCAM-1between baseline and 36-week follow-up

  42. the change in VCAM-1 [ Time Frame: 9 month ]
    percentage change in serum level of VCAM-1 between baseline and 36-week follow-up

  43. the change in ICAM-1 [ Time Frame: 9 month ]
    absolute change in serum level of ICAM-1 between baseline and 36-week follow-up

  44. the change in ICAM-1 [ Time Frame: 9 month ]
    percentage change in serum level of ICAM-1 between baseline and 36-week follow-up

  45. the change in free PCSK9 [ Time Frame: 9 month ]
    absolute change in serum level of free PCSK9 between baseline and 36-week follow-up

  46. the change in free PCSK9 [ Time Frame: 9 month ]
    percentage change in serum level of free PCSK9 between baseline and 36-week follow-up



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  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. Known hypersensitivity to alirocumab or rosuvastatin
  4. All contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments
  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. Pregnant or breast-feeding women
  10. Considered by the investigator as inappropriate for this study for any reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552432


Contacts
Contact: Hiromasa Otake, M.D, Ph,D +81-78-382-5846 hotake@med.kobe-u.ac.jp

Locations
Japan
Kobe University Graduate School of Medicine, Department of Cardiology Recruiting
Kobe, Hyogo, Japan, 650-0017
Contact: Hiromasa Otake, MD    +81783825846    hotake@med.kobe-u.ac.jp   
Sponsors and Collaborators
Kobe University
Investigators
Principal Investigator: Hiromasa Otake, M.D, Ph,D Kobe University Graduate School of Medicine

Responsible Party: Hiromasa Otake, Senior Lecturer, Kobe University
ClinicalTrials.gov Identifier: NCT03552432     History of Changes
Other Study ID Numbers: KobeU-290017
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hiromasa Otake, Kobe University:
alirocumab
Thin-cap fIbroatheroma (TCFA)
vulnerable plaque
Optical Coherence Tomography (OCT)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Plaque, Atherosclerotic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Rosuvastatin Calcium
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs