NCT04710368CompletedPhase 4
Effect of Evolocumab on Coronary Plaque Characteristics
Effect of Evolocumab on Coronary Plaque Characteristics: a Multimodality Imaging Study
Source: ClinicalTrials.gov · Last updated 18 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 137 (actual)
- First submitted
- 12 Jan 2021
- Start date
- 4 May 2021
- Primary completion date
- 28 Oct 2022
- Lead sponsor
- Annapoorna Kini
- Diseases
- Coronary artery disease
- NCT number
- NCT04710368
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 137
- From 4 May 2021 to the primary completion date, 28 Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are currently participating in another investigational drug/device study
Other illness
- 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 with left main disease, in-stent restenotic lesions or patients requiring coronary artery bypass graft surgery
- Patients with liver disease
- Patients having undergone heart transplantation, or those that may undergo heart transplantation during the study period
- Patients with active autoimmune disease
Lab values
- Patients with platelet count \< 100,000 cell/mm3
- Patient with creatinine \> 2.0 mg/dL
Other
- Patients who are in cardiogenic shock
- Patients with elevated CK-MB (\>6.3 ng/ml) or Tnl (\>0.5 ng/ml)
- Patients who have co-morbidity which reduces life expectancy to one year
- Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.