Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study
Identifieur interne : 000D53 ( Main/Exploration ); précédent : 000D52; suivant : 000D54Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study
Auteurs : Jordan Andrews [Australie] ; Alex Janssan [Australie] ; Tracy Nguyen [Australie] ; Anthony D. Pisaniello [Australie] ; Daniel J. Scherer [Australie] ; John J. P. Kastelein [Pays-Bas] ; Bela Merkely [Hongrie] ; Steven E. Nissen [États-Unis] ; Kausik Ray [Royaume-Uni] ; Gregory G. Schwartz [États-Unis] ; Stephen G. Worthley [Australie] ; Connie Keyserling [France] ; Jean-Louis Dasseux [France] ; Julie Butters [Australie] ; Jacinta Girardi [Australie] ; Rosemary Miller [Australie] ; Stephen J. Nicholls [Australie]Source :
- Cardiovascular Diagnosis and Therapy [ 2223-3652 ] ; 2017.
Abstract
High-density lipoprotein (HDL) is believed to have atheroprotective properties, but an effective HDL-based therapy remains elusive. Early studies have suggested that infusion of reconstituted HDL promotes reverse cholesterol transport and vascular reactivity. The CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT) is investigating the impact of infusing an engineered pre-beta HDL mimetic containing sphingomyelin (SM) and dipalmitoyl phosphatidlyglycerol (CER-001) on coronary atheroma volume in patients with a recent acute coronary syndrome (ACS).
The CARAT is a phase 2, multicenter trial in which 292 patients with an ACS undergoing intracoronary ultrasonography and showing percent atheroma volume (PAV) greater than 30% are randomly assigned to treatment with ten infusions of CER-001 3 mg/kg or matching placebo, administered at weekly intervals. Intracoronary ultrasonography is repeated at the end of the treatment period.
The primary endpoint is the nominal change in PAV. Safety and tolerability will also be evaluated.
CARAT will establish whether serial 3 mg/kg infusions of an engineered pre-beta HDL mimetic containing SM and dipalmitoyl phosphatidlyglycerol (CER-001) will regress atherosclerotic plaque in patients with a recent ACS.
Url:
DOI: 10.21037/cdt.2017.01.01
PubMed: 28164012
PubMed Central: 5253449
Affiliations:
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Pisaniello</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Scherer, Daniel J" sort="Scherer, Daniel J" uniqKey="Scherer D" first="Daniel J." last="Scherer">Daniel J. Scherer</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kastelein, John J P" sort="Kastelein, John J P" uniqKey="Kastelein J" first="John J. P." last="Kastelein">John J. P. Kastelein</name><affiliation wicri:level="1"><nlm:aff id="aff2">Academic Medical Center, University of Amsterdam, Amsterdam,<country>The Netherlands</country>;</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Merkely, Bela" sort="Merkely, Bela" uniqKey="Merkely B" first="Bela" last="Merkely">Bela Merkely</name><affiliation wicri:level="1"><nlm:aff id="aff3">Heart and Vascular Center, Semmelweis University, Budapest,<country>Hungary</country>;</nlm:aff><country xml:lang="fr">Hongrie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nissen, Steven E" sort="Nissen, Steven E" uniqKey="Nissen S" first="Steven E." last="Nissen">Steven E. Nissen</name><affiliation wicri:level="1"><nlm:aff id="aff4">Cleveland Clinic, Cleveland, Ohio,<country>USA</country>;</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ray, Kausik" sort="Ray, Kausik" uniqKey="Ray K" first="Kausik" last="Ray">Kausik Ray</name><affiliation wicri:level="1"><nlm:aff id="aff5">School of Public Health, Imperial College London, London,<country>UK</country>;</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Schwartz, Gregory G" sort="Schwartz, Gregory G" uniqKey="Schwartz G" first="Gregory G." last="Schwartz">Gregory G. Schwartz</name><affiliation wicri:level="1"><nlm:aff id="aff6">University of Colorado School of Medicine, Denver, CO,<country>USA</country>;</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Worthley, Stephen G" sort="Worthley, Stephen G" uniqKey="Worthley S" first="Stephen G." last="Worthley">Stephen G. Worthley</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Keyserling, Connie" sort="Keyserling, Connie" uniqKey="Keyserling C" first="Connie" last="Keyserling">Connie Keyserling</name><affiliation wicri:level="1"><nlm:aff id="aff7">Cerenis Pharmaceuticals, Toulouse,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dasseux, Jean Louis" sort="Dasseux, Jean Louis" uniqKey="Dasseux J" first="Jean-Louis" last="Dasseux">Jean-Louis Dasseux</name><affiliation wicri:level="1"><nlm:aff id="aff7">Cerenis Pharmaceuticals, Toulouse,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Butters, Julie" sort="Butters, Julie" uniqKey="Butters J" first="Julie" last="Butters">Julie Butters</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Girardi, Jacinta" sort="Girardi, Jacinta" uniqKey="Girardi J" first="Jacinta" last="Girardi">Jacinta Girardi</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Miller, Rosemary" sort="Miller, Rosemary" uniqKey="Miller R" first="Rosemary" last="Miller">Rosemary Miller</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nicholls, Stephen J" sort="Nicholls, Stephen J" uniqKey="Nicholls S" first="Stephen J." last="Nicholls">Stephen J. Nicholls</name><affiliation wicri:level="1"><nlm:aff id="aff1">South Australian Health and Medical Research Institute, University of Adelaide, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Cardiovascular Diagnosis and Therapy</title><idno type="ISSN">2223-3652</idno><idno type="eISSN">2223-3660</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>High-density lipoprotein (HDL) is believed to have atheroprotective properties, but an effective HDL-based therapy remains elusive. Early studies have suggested that infusion of reconstituted HDL promotes reverse cholesterol transport and vascular reactivity. The CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT) is investigating the impact of infusing an engineered pre-beta HDL mimetic containing sphingomyelin (SM) and dipalmitoyl phosphatidlyglycerol (CER-001) on coronary atheroma volume in patients with a recent acute coronary syndrome (ACS).</p></sec><sec><title>Methods</title><p>The CARAT is a phase 2, multicenter trial in which 292 patients with an ACS undergoing intracoronary ultrasonography and showing percent atheroma volume (PAV) greater than 30% are randomly assigned to treatment with ten infusions of CER-001 3 mg/kg or matching placebo, administered at weekly intervals. Intracoronary ultrasonography is repeated at the end of the treatment period.</p></sec><sec><title>Results</title><p>The primary endpoint is the nominal change in PAV. Safety and tolerability will also be evaluated.</p></sec><sec><title>Conclusions</title><p>CARAT will establish whether serial 3 mg/kg infusions of an engineered pre-beta HDL mimetic containing SM and dipalmitoyl phosphatidlyglycerol (CER-001) will regress atherosclerotic plaque in patients with a recent ACS.</p></sec></div></front></TEI><affiliations><list><country><li>Australie</li><li>France</li><li>Hongrie</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>États-Unis</li></country></list><tree><country name="Australie"><noRegion><name sortKey="Andrews, Jordan" sort="Andrews, Jordan" uniqKey="Andrews J" first="Jordan" last="Andrews">Jordan Andrews</name></noRegion><name sortKey="Butters, Julie" sort="Butters, Julie" uniqKey="Butters J" first="Julie" last="Butters">Julie Butters</name><name sortKey="Girardi, Jacinta" sort="Girardi, Jacinta" uniqKey="Girardi J" first="Jacinta" last="Girardi">Jacinta Girardi</name><name sortKey="Janssan, Alex" sort="Janssan, Alex" uniqKey="Janssan A" first="Alex" last="Janssan">Alex Janssan</name><name sortKey="Miller, Rosemary" sort="Miller, Rosemary" uniqKey="Miller R" first="Rosemary" last="Miller">Rosemary Miller</name><name sortKey="Nguyen, Tracy" sort="Nguyen, Tracy" uniqKey="Nguyen T" first="Tracy" last="Nguyen">Tracy Nguyen</name><name sortKey="Nicholls, Stephen J" sort="Nicholls, Stephen J" uniqKey="Nicholls S" first="Stephen J." last="Nicholls">Stephen J. Nicholls</name><name sortKey="Pisaniello, Anthony D" sort="Pisaniello, Anthony D" uniqKey="Pisaniello A" first="Anthony D." last="Pisaniello">Anthony D. Pisaniello</name><name sortKey="Scherer, Daniel J" sort="Scherer, Daniel J" uniqKey="Scherer D" first="Daniel J." last="Scherer">Daniel J. Scherer</name><name sortKey="Worthley, Stephen G" sort="Worthley, Stephen G" uniqKey="Worthley S" first="Stephen G." last="Worthley">Stephen G. Worthley</name></country><country name="Pays-Bas"><noRegion><name sortKey="Kastelein, John J P" sort="Kastelein, John J P" uniqKey="Kastelein J" first="John J. P." last="Kastelein">John J. P. Kastelein</name></noRegion></country><country name="Hongrie"><noRegion><name sortKey="Merkely, Bela" sort="Merkely, Bela" uniqKey="Merkely B" first="Bela" last="Merkely">Bela Merkely</name></noRegion></country><country name="États-Unis"><noRegion><name sortKey="Nissen, Steven E" sort="Nissen, Steven E" uniqKey="Nissen S" first="Steven E." last="Nissen">Steven E. Nissen</name></noRegion><name sortKey="Schwartz, Gregory G" sort="Schwartz, Gregory G" uniqKey="Schwartz G" first="Gregory G." last="Schwartz">Gregory G. Schwartz</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Ray, Kausik" sort="Ray, Kausik" uniqKey="Ray K" first="Kausik" last="Ray">Kausik Ray</name></noRegion></country><country name="France"><noRegion><name sortKey="Keyserling, Connie" sort="Keyserling, Connie" uniqKey="Keyserling C" first="Connie" last="Keyserling">Connie Keyserling</name></noRegion><name sortKey="Dasseux, Jean Louis" sort="Dasseux, Jean Louis" uniqKey="Dasseux J" first="Jean-Louis" last="Dasseux">Jean-Louis Dasseux</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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