Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial
NCT ID: NCT01201837
Last Updated: 2014-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
507 participants
INTERVENTIONAL
2011-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Weekly injection
Low Dose
CER-001 Low Dose
CER-001
Weekly injection
Mid Dose
CER-001 Mid Dose
CER-001
Weekly injection
High Dose
CER-001 High Dose
CER-001
Weekly injection
Interventions
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Placebo
Weekly injection
CER-001
Weekly injection
Eligibility Criteria
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Inclusion Criteria
* Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina)
* Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation
Exclusion Criteria
* Weight \>120 kg
* Angiographic evidence of \>50% stenosis of the left main artery
* Uncontrolled diabetes (HbA1C\>10%)
* Hypertriglyceridemia (\>500 mg/dL)
* Congestive heart failure (NYHA class III or IV)
* Ejection fraction \<35%
* Uncontrolled hypertension (SBP \>180 mm Hg)
* Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
75 Years
ALL
No
Sponsors
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Cerenis Therapeutics, SA
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Claude Tardif, MD
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute
Locations
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Heart Center Research LLC
Huntsville, Alabama, United States
Mayo Clinic - Arizona
Phoenix, Arizona, United States
VA San Diego Health Care Center
San Diego, California, United States
Palm Beach Heart Institute, LLC - Zasa Clinical Research
Boynton Beach, Florida, United States
Heart and Vascular Institute of Florida
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Saint Joseph Research Institute
Atlanta, Georgia, United States
The Care Group, LLC
Indianapolis, Indiana, United States
Suburban Hospital
Bethesda, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Detroit Medical Center (DMC) Cardiovascular Institute
Detroit, Michigan, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Alegent Research Center
Omaha, Nebraska, United States
Buffalo Heart Group
Buffalo, New York, United States
Buffalo Cardiology & Pulmonary Associates
Williamsville, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Sanford Heart Center
Fargo, North Dakota, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Sanford Research / USD
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Dallas VA Medical Center
Dallas, Texas, United States
MultiCare Health System Research Institute / Cardiac Study Center
Tacoma, Washington, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
St. John Health Center
St. John's, Newfoundland and Labrador, Canada
London Health Sciences Center
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre de Santé et de Services Sociaux de Laval
Laval, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Montreal General Hospital Research Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
CSSS du Nord de Lanaudière
Saint-Charles-Borromée, Quebec, Canada
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivières, Quebec, Canada
Hôpital Cardiologique du Haut-Lévesque
Bordeaux, Pessac Cedex, France
Clinique Pasteur
Toulouse, , France
Centre Hospitalier Universitaire de Toulouse Rangueil
Toulouse, , France
Onze Lieve Vrouwe Gasthius
Amsterdam, AC, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, AD, Netherlands
Medisch Centrum Alkmaar
Alkmaar, Amsterdam, Netherlands
Academic Medical Center
Amsterdam, AZ, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, CM, Netherlands
Maassstadziekenhuis Cardiology Research
Rotterdam, DZ, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, EJ, Netherlands
Medisch Spectrum Twente
Enschede, ER, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, SZ, Netherlands
Countries
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References
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Nanjee MN, Doran JE, Lerch PG, Miller NE. Acute effects of intravenous infusion of ApoA1/phosphatidylcholine discs on plasma lipoproteins in humans. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):979-89. doi: 10.1161/01.atv.19.4.979.
Eriksson M, Carlson LA, Miettinen TA, Angelin B. Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I. Potential reverse cholesterol transport in humans. Circulation. 1999 Aug 10;100(6):594-8. doi: 10.1161/01.cir.100.6.594.
Spieker LE, Sudano I, Hurlimann D, Lerch PG, Lang MG, Binggeli C, Corti R, Ruschitzka F, Luscher TF, Noll G. High-density lipoprotein restores endothelial function in hypercholesterolemic men. Circulation. 2002 Mar 26;105(12):1399-402. doi: 10.1161/01.cir.0000013424.28206.8f.
Nieuwdorp M, Vergeer M, Bisoendial RJ, op 't Roodt J, Levels H, Birjmohun RS, Kuivenhoven JA, Basser R, Rabelink TJ, Kastelein JJ, Stroes ES. Reconstituted HDL infusion restores endothelial function in patients with type 2 diabetes mellitus. Diabetologia. 2008 Jun;51(6):1081-4. doi: 10.1007/s00125-008-0975-2. Epub 2008 Apr 4. No abstract available.
Drew BG, Duffy SJ, Formosa MF, Natoli AK, Henstridge DC, Penfold SA, Thomas WG, Mukhamedova N, de Courten B, Forbes JM, Yap FY, Kaye DM, van Hall G, Febbraio MA, Kemp BE, Sviridov D, Steinberg GR, Kingwell BA. High-density lipoprotein modulates glucose metabolism in patients with type 2 diabetes mellitus. Circulation. 2009 Apr 21;119(15):2103-11. doi: 10.1161/CIRCULATIONAHA.108.843219. Epub 2009 Apr 6.
Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM. Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque. Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063. Epub 2008 Oct 2.
Waksman R, Torguson R, Kent KM, Pichard AD, Suddath WO, Satler LF, Martin BD, Perlman TJ, Maltais JA, Weissman NJ, Fitzgerald PJ, Brewer HB Jr. A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 15;55(24):2727-35. doi: 10.1016/j.jacc.2009.12.067.
Tardif JC, Gregoire J, L'Allier PL, Ibrahim R, Lesperance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodes-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. doi: 10.1001/jama.297.15.jpc70004. Epub 2007 Mar 26.
Nissen SE, Tsunoda T, Tuzcu EM, Schoenhagen P, Cooper CJ, Yasin M, Eaton GM, Lauer MA, Sheldon WS, Grines CL, Halpern S, Crowe T, Blankenship JC, Kerensky R. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2292-300. doi: 10.1001/jama.290.17.2292.
Tardif JC, Ballantyne CM, Barter P, Dasseux JL, Fayad ZA, Guertin MC, Kastelein JJ, Keyserling C, Klepp H, Koenig W, L'Allier PL, Lesperance J, Luscher TF, Paolini JF, Tawakol A, Waters DD; Can HDL Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial. Eur Heart J. 2014 Dec 7;35(46):3277-86. doi: 10.1093/eurheartj/ehu171. Epub 2014 Apr 29.
Other Identifiers
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CER-001-CLIN-002
Identifier Type: -
Identifier Source: org_study_id
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