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Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound (ANTARES)

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ClinicalTrials.gov Identifier: NCT03529253
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hiromasa Otake, Kobe University

Brief Summary:
The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina Pectoris Drug: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily Drug: Rosuvastatin calcium10mg Phase 4

Detailed Description:
The investigators investigate the change in the maxLCBI (4 mm) value calculated by NIRS-IVUS at the time of PCI and at the treatment evaluation after 9 months compared with the group of Alirocumab(Alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). And also the investigators evaluate LCBI(lesion), Angle of a lipid core, EEM CSA, Lumen CSA, Minimum lumen diameter, Plaque burden, Lesion length by NIRS-IVUS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive therapy group
Alirocumab group is Alirocumab75mg/2week plus Rosuvastatin10mg/daily.
Drug: Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily
Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.

Active Comparator: Standard therapy group
The standard therapy group is Rosuvastatin10mg/daily alone.
Drug: Rosuvastatin calcium10mg
Rosuvastatin10mg/daily by oral for 9 months.




Primary Outcome Measures :
  1. maxLCBI (4mm) [ Time Frame: baseline and 9 months ]

Secondary Outcome Measures :
  1. change amount of LCBI(lesion) [ Time Frame: baseline and 9 months ]
  2. change amount of Angle of lipid core [ Time Frame: baseline and 9 months ]
  3. change amount of LDL-Cholesterol level [ Time Frame: baseline and 9 months ]


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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:

  • Patients who underwent PCI for ACS or stable coronary heart disease
  • Patients with LDL-C ≥70 mg/dL under daily 10mg rosuvastatin
  • Patients who remained 25-75% stenosis with coronary angiography
  • Patients who obtained analyzable images and calculated maxLCBI (4 mm) with NIRS-IVUS
  • Patients aged ≥20 years old at PCI
  • Patients who agree to be enrolled in the trial give signed written informed consent

Exclusion Criteria:

  • 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
  • Patients on lipoprotein apheresis
  • Patients with severe liver or renal dysfunction
  • Pregnant or breastfeeding women
  • Patients recognized as inadequate by attending physician

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): NCT03529253


Contacts
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Contact: Hiromasa Otake, MD, PhD 078-382-5846 hotake@med.kobe-u.ac.jp

Locations
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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

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Responsible Party: Hiromasa Otake, senior lecturer, Kobe University
ClinicalTrials.gov Identifier: NCT03529253     History of Changes
Other Study ID Numbers: 290068
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
NIRS-IVUS
LCBI
Additional relevant MeSH terms:
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Chest Pain
Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Signs and Symptoms
Rosuvastatin Calcium
Antibodies, Monoclonal
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Immunologic Factors