Effect of Evolocumab on Coronary Plaque Characteristics

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2023-11-06

Brief Summary

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The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study combines multi-modality intravascular imaging approaches and transcriptomic based machine learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in atherosclerotic lesions of patients treated with evolocumab. The primary end-points are the changes from baseline to follow-up in (1) the minimal fibrous cap thickness (FCT) assessed by optical coherence tomography (OCT) and (2) maxLCBI4mm assessed by near-infrared spectroscopy (NIRS) after 26 weeks of evolocumab. The secondary endpoints are the changes in (1) the maximal lipid arc, lipid length, lipid volume index, macrophage accumulation and calcification by OCT; (2) PAV and TAV defined by intravascular ultrasound (IVUS) and (3) Changes in PBMC gene expression.

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Detailed Description

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The single center single arm study will be performed in the Cardiac Catheterization laboratory of the Mount Sinai Hospital, New York, NY. After informed consent, patients undergoing clinically indicated elective PCI with a non-obstructive lesion and optimal background statin therapy will be eligible screening. Non-obstructive lesions (30-50% stenosis) identified by angiography in a non-culprit vessel with lipid-rich plaque will be studied. Subjects will receive evolocumab (Repatha) 140 mg subcutaneously every 2 weeks for 26 weeks. Serial NIRS/IVUS and OCT imaging will be performed in the non-obstructive lesions, first during PCI and subsequently after 26 weeks. A total of 25ml of blood will be drawn from the sheath during angiography for transcriptomic profiling of PBMC.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study team will screen patients scheduled for elective PCI, who are receiving statin therapy for at least 4 weeks with acceptable LDL-C levels. Patients with non-obstructive lesion (30-50% stenosis) by angiography and lipid-rich plaque with lipid arc \>90° and minimal fibrous cap thickness ≤ 120 µm detected by OCT will comprise the final study population. Serial NIRS/IVUS and OCT imaging will be performed in a non-target lesions, first during PCI and subsequently after 26 weeks.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment

Evolocumab subcutaneously administered 140 mg every 2 weeks for 26 weeks

Group Type EXPERIMENTAL

Evolocumab Injections

Intervention Type DRUG

Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens.

Interventions

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Evolocumab Injections

Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens.

Intervention Type DRUG

Other Intervention Names

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Repatha

Eligibility Criteria

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Inclusion Criteria

* Men or women aged 18 years or older at screening who signed written Informed Consent
* Patients with coronary artery disease undergoing cardiac catheterization and PCI for a target lesion and also have a non-obstructive lesion (30-50% stenosis) identified by angiography
* Patients who are not candidates for PCI or CABG currently or over the next 12 months, in the opinion of the investigator
* Patients treated with statins for at least 4 weeks with LDL-C level ≥ 80 mg/dL for low- or moderate -intensity statin use and ≥ 60 mg/dL for high-dose statin. Patients with history of statin intolerance and LDL-C ≥ 100 mg/dL.
* Angiographic criteria: 30-50% reduction of lumen diameter in addition to the target lesion accessible by the OCT catheter. The target segment should not have a history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), and may not be a bypass graft.
* OCT criteria: target segment should have a lipid-rich plaque with lipid arc \>90° and fibrous cap thickness ≤120 µm.
* Women of childbearing potential must agree to be on an acceptable method of birth control/contraceptive

Exclusion Criteria

* Patients who have acute myocardial infarction (Q wave or non-Q wave with CK-MB \> 5 times above the upper normal (31.5 ng/ml) within 72 hours)
* Patients who are in cardiogenic shock
* Patients with left main disease, in-stent restenotic lesions or patients requiring coronary artery bypass graft surgery
* Patients with elevated CK-MB (\>6.3 ng/ml) or Tnl (\>0.5 ng/ml)
* Patients with platelet count \< 100,000 cell/mm3
* Patients who have co-morbidity which reduces life expectancy to one year
* Patients who are currently participating in another investigational drug/device study
* Patients with liver disease
* Patient with creatinine \> 2.0 mg/dL
* Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
* Patients having undergone heart transplantation, or those that may undergo heart transplantation during the study period
* Patients with active autoimmune disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No