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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 : June 11, 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 ]

Secondary Outcome Measures :
  1. the change in lipid index [ Time Frame: 9 month ]
  2. the change in lipid length, [ Time Frame: 9 month ]
  3. the change in mean lipid arc [ Time Frame: 9 month ]
  4. the change in max lipid arc [ Time Frame: 9 month ]
  5. the change in macrophage grade [ Time Frame: 9 month ]
    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

  6. the number of thin-cap fibroatheroma [ Time Frame: 9 month ]
  7. the change in lipid parameters [ Time Frame: 9 month ]
    including LDL-cholesterol, HDL-cholesterol, total-cholesterol, Lipoprotain(a)

  8. the change in hs-CRP [ Time Frame: 9 month ]
  9. the change in IL-6 [ Time Frame: 9 month ]
  10. the change in TNF-α [ Time Frame: 9 month ]
  11. the change in MCP-1 [ Time Frame: 9 month ]
  12. the change in MMP-2, and MMP-9 [ Time Frame: 9 month ]
  13. the change in VCAM-1, and ICAM-1 [ Time Frame: 9 month ]


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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 received PCI for acute coron ary syndrome or stable angina
  2. Patients had received or started after PCI statin therapy
  3. OCT images could obtained and vuln erable plaques were presence
  4. Patients over 20 years old
  5. Written consent for participation in th e study

Exclusion Criteria:

1)Patients had one or more administration of anti-PSCK9 monoclonal Antibody 2)Patients had uncontroled hypertensio n before Visit 1 3)Patients with well controlled LDL-C:7 0mg/dl or less 4)Past medical history of hypersensitivit y to investigational drugs 5)Patients had past medical history of H emorrhagic stroke 6)Patients received Anticancer drug 7)Patients received LDL-aphelesis 8)Patienta had severe liver or renal fun ction 9)10)Patients had contraindication of in vestigational drugs 11)pregnant, lactating, and possibly pre gnant women and those planning to be come pregnant 12)judged as ineligible by clinical invest igators


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: June 11, 2018
Last Verified: May 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