Effects of the PCSK9 antibody alirocumab on coronary atherosclerosis in patients with acute myocardial infarction: a serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical coherence tomography imaging study-Rationale and design of the PACMAN-AMI trial.
Abstract | BACKGROUND: AIMS: To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI4 mm) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI. METHODS: In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg. Patients undergo serial IVUS, NIRS and OCT in the two non- infarct related arteries at baseline (at the time of treatment of the culprit lesion) and at 52 weeks. The primary endpoint, change in IVUS-derived PAV, and the powered secondary endpoints, change in NIRS-derived maxLCBI4 mm, and OCT-derived minimal FCT, will be assessed 52 weeks post randomization. SUMMARY: The PACMAN-AMI trial will determine the effect of alirocumab on top of high-intensity statin therapy on high-risk coronary plaque characteristics as assessed by serial, multimodality intracoronary imaging in patients presenting with AMI. CLINICAL TRIAL REGISTRATION: NCT03067844.
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Authors | Christian Zanchin, Konstantinos C Koskinas, Yasushi Ueki, Sylvain Losdat, Jonas D Häner, Sarah Bär, Tatsuhiko Otsuka, Andrea Inderkum, Maria Radu Juul Jensen, Jacob Lonborg, Gregor Fahrni, Anna S Ondracek, Joost Daemen, Robert-Jan van Geuns, Juan F Iglesias, Christian M Matter, David Spirk, Peter Juni, Francois Mach, Dik Heg, Thomas Engstrom, Irene Lang, Stephan Windecker, Lorenz Räber |
Journal | American heart journal
(Am Heart J)
Vol. 238
Pg. 33-44
(08 2021)
ISSN: 1097-6744 [Electronic] United States |
PMID | 33951415
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021. Published by Elsevier Inc. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Cholesterol, LDL
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Placebos
- Rosuvastatin Calcium
- PCSK9 protein, human
- Proprotein Convertase 9
- alirocumab
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Topics |
- Antibodies, Monoclonal, Humanized
(administration & dosage)
- Cholesterol, LDL
- Coronary Artery Disease
(diagnostic imaging, drug therapy)
- Double-Blind Method
- Drug Administration Schedule
- Endosonography
- Europe
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Myocardial Infarction
(complications)
- Non-ST Elevated Myocardial Infarction
(complications)
- Placebos
(administration & dosage)
- Plaque, Atherosclerotic
(diagnostic imaging, drug therapy)
- Proprotein Convertase 9
(immunology)
- Research Design
- Rosuvastatin Calcium
(administration & dosage)
- ST Elevation Myocardial Infarction
(complications)
- Spectroscopy, Near-Infrared
- Tomography, Optical Coherence
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